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 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
NCT ID:
NCT05590403
Description:
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
Frequency Threshold:
0
Time Frame:
Solicited AEs were collected from Day 1 (day of vaccination) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. SAEs and pIMDs were collected from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs and fatal SAEs were collected from Day 1 up to study end (Month 12).
Study:
NCT05590403
Study Brief:
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adults HA-RSV Group | Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 0 | None | 3 | 383 | 325 | 383 | View |
| Adults HA-Placebo Group | Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. | 0 | None | 4 | 192 | 76 | 192 | View |
| Adults AIR-Placebo Group | Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end. | 1 | None | 4 | 191 | 74 | 191 | View |
| OA-RSV Group | Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 0 | None | 9 | 381 | 279 | 381 | View |
| Adults AIR-RSV Group | Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end. | 1 | None | 15 | 386 | 318 | 386 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cold type haemolytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Non-alcoholic fatty liver | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v27.0 | View |
| Abscess oral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Infective exacerbation of chronic obstructive airways disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Kyphosis postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Gouty arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Cerebellar stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Ocular retrobulbar haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Abdominal wall haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Noninfective sialoadenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Poor dental condition | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Administration site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Administration site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Hepatic fibrosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v27.0 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v27.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Eczema nummular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Macule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Administration site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Administration site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Administration site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Tendon pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Cervicobrachial syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Chronic sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Labyrinthitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Suspected COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Immunisation reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Post-traumatic pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Helicobacter test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hyperphagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Impaired fasting glucose | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Vitamin B12 deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Muscle contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Carotid arteriosclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Post herpetic neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Sinus headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |