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: 2025-12-25 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT00355134
Description: None
Frequency Threshold: 5
Time Frame: Duration of treatment was up to 24 months during the Core phase, and dependent on the length of patient participation during the Extension phase (up to approximately 54 months overall duration of treatment).
Study: NCT00355134
Study Brief: Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Core: Fingolimod 1.25 mg Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. None None 53 370 335 370 View
Core: Fingolimod 0.5 mg Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. None None 53 358 320 358 View
Core: Placebo Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day. None None 45 355 305 355 View
Extension: Fingolimod 1.25 mg Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. None None 27 308 216 308 View
Extension: Fingolimod 0.5 mg Participants received 0.5 mg fingolimod orally once a day in the Extension phase. None None 21 324 223 324 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetes insipidus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Drug dependence SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Frustration SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Idiopathic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Caecitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pelvic mass SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bartholin's abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Encephalitis herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lyme disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Drug exposure during pregnancy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Morphoea SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Astrocytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dysplastic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ependymoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hair follicle tumour benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Parathyroid tumour benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Sarcoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
T-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Thyroid adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Simple partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Acute psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cervical cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cystocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Haemorrhagic ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Rectocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Uterovaginal prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View