Adverse Events Module

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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT04032093
Description: Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Maternal safety population was evaluated for maternal participants and Infant safety population for infant participants.
Frequency Threshold: 1
Time Frame: Local reactions and systematic events (systematic assessment): within 7 days after vaccination. AEs and SAEs (non-systematic assessment): From day of vaccination (Day 1) up to 12 months post-delivery for maternal participants and from birth up to 12 months after birth for infant participants
Study: NCT04032093
Study Brief: A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Maternal Participants: RSVpreF 120 mcg Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. 0 None 7 115 87 115 View
Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. 0 None 15 117 108 117 View
Maternal Participants: RSVpreF 240 mcg Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. 0 None 15 116 96 116 View
Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. 0 None 19 114 103 114 View
Maternal Participants: Placebo Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery. 0 None 14 117 89 117 View
Infant Participants: RSVpreF 120 mcg Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. 0 None 41 114 66 114 View
Infant Participants: RSVpreF 240 mcg Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. 0 None 35 113 67 113 View
Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. 0 None 44 112 66 112 View
Infant Participants: Placebo Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth. 0 None 38 116 71 116 View
Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. 0 None 39 117 59 117 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nonreassuring foetal heart rate pattern NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
False labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature delivery NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Cryptorchism NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v24.1 View
Respiratory syncytial virus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Anaemia of pregnancy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Blood loss anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Baseline foetal heart rate variability disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Foetal heart rate deceleration abnormality NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Tachycardia foetal NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v24.1 View
Amniotic cavity infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Anorectal cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Endometritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Endometritis decidual NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Mastitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Oophoritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Salpingitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Uterine rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Foetal heart rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Foetal heart rate indeterminate NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Influenza virus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Osteitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Arrested labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Cephalo-pelvic disproportion NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Ectopic pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Foetal death NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Foetal distress syndrome NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Foetal growth restriction NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Foetal hypokinesia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Gestational hypertension NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Oligohydramnios NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Postpartum haemorrhage NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature separation of placenta NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Prolonged rupture of membranes NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Retained placenta or membranes NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Umbilical cord abnormality NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Uterine tachysystole NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Mitral valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Alpers disease NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Ankyloglossia congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Aplasia cutis congenita NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Atrial septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Birth mark NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Chordee NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Chromosomal deletion NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Cleft lip NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Cleft palate NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Congenital coronary artery malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Congenital naevus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Congenital skin dimples NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Congenital tracheomalacia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Congenital umbilical hernia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Dacryostenosis congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Developmental hip dysplasia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Double ureter NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Gastrointestinal disorder congenital NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Haemoglobin D trait NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Hypospadias NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Labial tie NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Laryngomalacia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Naevus flammeus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Patent ductus arteriosus NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Penile torsion NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Penoscrotal fusion NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Phimosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Polydactyly NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Spina bifida cystica NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Supernumerary nipple NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Vascular malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Ventricular septal defect NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
XYY syndrome NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v24.1 View
Gingival cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Intussusception NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Tongue cyst NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Infusion site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v24.1 View
Adenovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Gastroenteritis salmonella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Postoperative adhesion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Acoustic stimulation tests abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Cardiac murmur functional NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Right ventricular systolic pressure NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Acrochordon NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v24.1 View
Haemangioma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v24.1 View
Haemangioma of skin NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v24.1 View
Melanocytic naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v24.1 View
Brain hypoxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Clonic convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Encephalopathy neonatal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Peripheral nerve palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Jaundice neonatal NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Low birth weight baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v24.1 View
Testicular retraction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Cafe au lait spots NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Macule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Subgaleal haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Meconium aspiration syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal respiratory depression NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Neonatal respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Tachypnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Transient tachypnoea of the newborn NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.1 View
Nonreassuring foetal heart rate pattern NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v24.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Diarrhoea (DIARRHOEA) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Nausea (NAUSEA) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Vomiting (VOMITING) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Fatigue (FATIGUE) SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Injection site erythema (REDNESS) SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Injection site pain (PAIN AT INJECTION SITE) SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Injection site swelling (SWELLING) SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Perineal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Vulvovaginal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Bacterial test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Streptococcus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Arthralgia (JOINT PAIN) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Myalgia (MUSCLE PAIN) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Headache (HEADACHE) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.1 View
Foetal hypokinesia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Gestational diabetes NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Gestational hypertension NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature delivery NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Shoulder dystocia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Perinatal depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v24.1 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.1 View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v24.1 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Dacryostenosis acquired NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v24.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.1 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v24.1 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v24.1 View
Acne infantile NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Seborrhoea NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.1 View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.1 View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v24.1 View
Acquired plagiocephaly NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Torticollis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.1 View
Jaundice neonatal NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Low birth weight baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Premature baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Umbilical granuloma NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA v24.1 View
Neonatal respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Respiratory disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Tachypnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Transient tachypnoea of the newborn NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v24.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Conjunctivitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Ear infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Otitis media acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Skin candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Pyrexia (FEVER) SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.1 View
Bacterial disease carrier NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Mastitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.1 View