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Table 3 Perinatal Adverse Events

From: A retrospective analysis of incident pregnancy in phase 1 and 2a HIV-1 vaccine study participants does not support concern for adverse pregnancy or birth outcomes

 

Adverse Fetal Events

Adverse Maternal Events

Severity

Event

Severity

Event

Product recipients (n = 154 pregnancies)

Severe

Congenital anomaly in offspring

Death

Shock

Severe

Congenital anomaly in offspring (Poland’s syndrome)

Life Threatening

HIV infected

Severe

Hepatic Mesenchymal Hamartoma in Offspring

Severe

Pelvic Pain

  

Severe

Placenta previa

  

Moderate

Back Pain r/t herniated disk

  

Moderate

Gastritis

  

Moderate

Headache

  

Moderate

Infected wisdom teeth - upper left + lower left

  

Moderate

Insomnia

  

Moderate

Left chest pains

  

Moderate

Proteinuria

  

Moderate

Sinusitis

  

Moderate

Vaginal colonization with Group B strep

  

Moderate

Wisdom teeth impaction - upper left + lower left

Placebo recipients (n = 39 pregnancies)

  

Severe

Incomplete abortion

  

Severe

Increase interval (432 ms) from baseline QTc interval

  

Moderate

Macro hematuria post therapeutic abortion

  

Moderate

Pre-eclampsia

  

Moderate

Retained placenta (with postpartum pyrexia)