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 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
NCT ID:
NCT01618305
Description:
Serious adverse events and deaths were reported among all women and live-birth infants. Only women who received at least one dose of study drug (and their infants) were included in the assessment of "other" events, which included grade 3 or higher signs/symptoms, laboratory events, and diagnoses that occurred in at least 5 percent of women (or infants) in at least one arm.
The DAIDS AE Grading Table (V2.0) and EAE Manual (V2.0) were used.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected from entry (20-36 weeks gestation) through delivery for women. Additionally, both women and infants had adverse event data collected from delivery through their final study visit which was scheduled to occur at Week 24 postpartum.
Study:
NCT01618305
Study Brief:
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
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 A (Women) | Pregnant women received ZDV/3TC + EFV Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery\*. \* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Efavirenz: Participants received one 600 mg tablet of efavirenz each night from entry through delivery. | 0 | None | 34 | 202 | 20 | 197 | View |
| Arm B (Women) | Pregnant women received ZDV/3TC + RAL Lamivudine/zidovudine: Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery\*. \* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization. Raltegravir: Participants received one 400 mg raltegravir tablet twice a day from entry through delivery. | 1 | None | 34 | 206 | 24 | 206 | View |
| Arm A (Infants) | Infants born to women in Arm A; infants received no study intervention. | 1 | None | 31 | 194 | 20 | 194 | View |
| Arm B (Infants) | Infants born to women in Arm B; infants received no study intervention. | 1 | None | 50 | 199 | 15 | 199 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABO incompatibility | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Abortion threatened | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Cardiac murmer | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Congenital cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Congenital pneumonia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Congenital syphilis | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Congenital toxoplasmosis | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Genitalia external ambiguous | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Gestational diabetes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Hepatic rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.1) | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (22.1) | View |
| Herpes simplex encephalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.1) | View |
| Hyperbilirubinaemia neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.1) | View |
| Hypospadias | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Neonatal asphyxia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Neonatal respiratory distress | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Pelvis abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Polyhydramnios | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Postpartum haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Premature baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Premature labor | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Premature rupture of membranes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Puerperal pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| Pulmonary artery stenosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Pulmonary valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Pyloric stenosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Sudden infant death syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (22.1) | View |
| Talipes | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.1) | View |
| Transient tachypnoea of the newborn | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Tricuspid valve incompetance | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.1) | View |
| Umbilical cord around neck | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (22.1) | View |
| Ankyloglossia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Single umbilical artery | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Infection prophylaxis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (22.1) | View |
| Macrocephaly | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Necrotising colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Foetal death | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Bicytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| Foetal malformation | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Pyelocaliectasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.1) | View |
| Extrapulmonary tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Low birth weight baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (22.1) | View |
| Hypoxic-ischaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.1) | View |
| Foetal growth restriction | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Gestational hypertension | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Congenital skin dimples | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (22.1) | View |
| Escherichia pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Meconium aspiration syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Foetal distress syndrome | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| Neonatal respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| Oligohydramnios | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| Respiratory syncytial virus bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| Sepsis neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | View |