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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT01193920
Description: Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment.
Frequency Threshold: 5
Time Frame: Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361.
Study: NCT01193920
Study Brief: Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-pregnant 20/20/20 μg +Aluminum Hydroxide Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum None None 2 40 40 40 View
Non-pregnant/Placebo Non-pregnant women received two injections of saline solution None None 1 20 19 20 View
Pregnant 0.5/0.5/0.5 μg Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine None None 27 80 72 80 View
Pregnant 2.5/2.5/2.5 μg Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine None None 24 80 67 80 View
Pregnant 5/5/5 μg Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine None None 25 80 70 80 View
Pregnant/Placebo Pregnant women who received one injection of saline solution None None 30 80 71 80 View
Infants 0.5/0.5/0.5 μg Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine None None 19 79 44 79 View
Infants 2.5/2.5/2.5 μg Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine None None 13 79 49 79 View
Infants 5/5/5 μg Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine None None 13 74 48 74 View
Infants / Placebo Infants born from women who received one injection of saline solution None None 18 78 51 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thyroid mass NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
strabism NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
constipation None Gastrointestinal disorders MedDRA View
diarrhoea None Gastrointestinal disorders MedDRA View
vomiting None Gastrointestinal disorders MedDRA View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
abscess limb None Infections and infestations MedDRA View
acute tonsillitis None Infections and infestations MedDRA View
bullous impetigo None Infections and infestations MedDRA View
cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
chorioamnionitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
dysentery NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
eczema herpeticum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HIV infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
klebsiella sepsis None Infections and infestations MedDRA View
lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
postpartum sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
pyelonephritis None Infections and infestations MedDRA View
streptococcal sepsis None Infections and infestations MedDRA View
umbilical sepsis None Infections and infestations MedDRA View
upper respiratory tract infection None Infections and infestations MedDRA View
urinary tract infection None Infections and infestations MedDRA View
urinary tract infection bacteria None Infections and infestations MedDRA View
wound sepsis None Infections and infestations MedDRA View
burns second degree None Injury, poisoning and procedural complications MedDRA View
perineal laceration None Injury, poisoning and procedural complications MedDRA View
post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
vulvovaginal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
wound secretion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
hypernatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
convulsion neonatal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
hypoxic-ischaemic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
abortion spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
jaundice neonatal NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
low birth weight baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
cephalo-pelvic disproportion NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
failed induction of labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
false labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
foetal death NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
foetal distress syndrome NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
foetal hypokinesia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
gestational hypertension NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
oligohydramnios NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
postpartum haemorrage NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
premature labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
premature rupture of membranes NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
premature separation of placenta NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
prolonged labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
prolonged pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
retained product of conception NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
stillbirth NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
umbilical cord prolapse NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
vaginal haemorrage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
neonathal asphyxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
transient tachypnoea of the newborn NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
erythema toxicum neonatorum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
labour induction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
subgaleal haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Tachycardia foetal NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
cardiac disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
congenital pneumonia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
bronchiolitis None Infections and infestations MedDRA View
bronchopneumonia None Infections and infestations MedDRA View
respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
sepsis None Infections and infestations MedDRA View
sepsis neonatal None Infections and infestations MedDRA View
hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
coagulation factor IX level decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
premature baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
breech presentation NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
haemorrage in pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
hyperemesis gravidarum NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
labour complication NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
injection site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA View
malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
pain None General disorders MedDRA View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
tonsillitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
vaginal discharge None Reproductive system and breast disorders MedDRA View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
constipation None Gastrointestinal disorders MedDRA View
jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
fungal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
dermatitis diaper NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View