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 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
NCT ID:
NCT02717494
Description:
For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Frequency Threshold:
5
Time Frame:
For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window).
Study:
NCT02717494
Study Brief:
Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected 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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1A (PPV-23) | In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes. | 0 | None | 15 | 115 | 66 | 115 | View |
| Arm 1B (PCV-10) | In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes. | 0 | None | 15 | 115 | 63 | 115 | View |
| Arm 1C (Placebo) | In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy. | 1 | None | 16 | 116 | 62 | 116 | View |
| Arm 2A (PPV-23) | In Step 2, women in Arm 2A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes. | 0 | None | 0 | 53 | 5 | 53 | View |
| Arm 2B (PCV-10) | In Step 2, women in Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes. | 0 | None | 0 | 53 | 7 | 53 | View |
| Infants of Mothers in Arm 1A (PPV-23) | These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes. | 1 | None | 20 | 114 | 9 | 115 | View |
| Infants of Mothers in Arm 1B (PCV-10) | These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes. | 1 | None | 21 | 116 | 8 | 117 | View |
| Infants of Mothers in Arm 1C (Placebo) | These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy. | 0 | None | 19 | 119 | 17 | 119 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22 | View |
| Pancreatic mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 22 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Endometritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Pulmonary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Uterine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Incision site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Post lumbar puncture syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22 | View |
| Anogenital warts | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22 | View |
| Eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Foetal distress syndrom | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Oligohydramnios | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Postpartum haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Premature labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Threatened labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Gestational hypertension | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Preterm premature rupture | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 22 | View |
| Pulmonary valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22 | View |
| Congenital diaphragmatic hernia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 22 | View |
| Congenital hydrocephalus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 22 | View |
| Congenital syphilis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 22 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22 | View |
| Fever neonatal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22 | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Neurosyphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Sepsis neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22 | View |
| Jaundice neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Premature baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Foetal growth restriction | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | View |
| Neonatal asphyxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Neonatal respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Respiratory depression | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Transient tachypnoea of newborn | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Neonatal hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Dermatitis bullous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 22 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | View |