Adverse Events Module

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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 @ 9:35 PM
Ignite Modification Date: 2025-12-25 @ 7:18 PM
NCT ID: NCT03094832
Description: All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Frequency Threshold: 5
Time Frame: Up to approximately 48 months
Study: NCT03094832
Study Brief: Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Miransertib PROS/PS During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion. 1 None 4 17 17 17 View
Part B: Miransertib PROS (Cohort 1) During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion. 0 None 3 22 18 22 View
Part B: Miransertib PS (Cohort 2) During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion. 0 None 0 1 0 1 View
Part B: Miransertib PROS/PS (Cohort 3) During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion. 0 None 1 8 6 8 View
Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2). 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Immune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.1 View
Vascular malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Salivary duct obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Swollen tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Lithiasis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Anion gap SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood insulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Bone density decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Fibrin D dimer decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Haematocrit increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Monocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Urine ketone body present SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperinsulinaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Petit mal epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Enuresis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Oedema genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Perineal erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Testicular oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Vulvovaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Bradypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Tonsillolith SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Upper respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Bullous haemorrhagic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Perioral dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pityriasis rosea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Lymphorrhoea SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Venous haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View