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 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
NCT ID:
NCT05921903
Description:
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Frequency Threshold:
0
Time Frame:
Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 4 (Visit 3 + 30-42 days).
Study:
NCT05921903
Study Brief:
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 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 |
|---|---|---|---|---|---|---|---|---|
| RSV_IC_1 Group | Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 0 | None | 12 | 131 | 106 | 131 | View |
| RSV_IC_2 Group | IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). | 2 | None | 18 | 130 | 120 | 130 | View |
| RSV_HA Group | Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | 0 | None | 3 | 125 | 111 | 125 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Aspergillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Bursitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gastroenteritis Escherichia coli | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Oropharyngeal squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Myelodysplastic syndrome with excess blasts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Eyelid ptosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Anaphylactic shock | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v27.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Lymph gland infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Herpes simplex reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Pneumonia pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Stenotrophomonas maltophilia pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Bronchiectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Paranasal sinus discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Increased upper airway secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Administration site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Administration site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Vaccination site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v27.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Brain fog | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Bursitis | 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 |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Abdominal wall haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Intestinal mucosal hypertrophy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Retroperitoneal haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Haemorrhage subcutaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v27.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v27.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Major depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Nipple pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
| Small intestine adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Blood magnesium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v27.0 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Ear congestion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v27.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 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 |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v27.0 | View |