TABLE 4.4Infant Clinical Serious Adverse Events Found Only in the Source Documents

Committee Review Identification NumbersTreatment ArmMissed SAEs According to Committee ReviewConcurrent SAEs Reported in CRFs
1NVPFever, oral thrush, dehydration, electrolyte imbalance, hypotonic at month 6Diarrhea and marasmus at month 6
4ZDVMalaria, respiratory distress at week 15Dehydration and diarrhea at week 15
6aNVP (drug not given; infant died at birth)Prematurity at birthRespiratory distress at birth
6bNVP (drug not given; infant died at birth)Prematurity at birthRespiratory distress at birth
13NVPMalaria week 15 Pneumonia month 9Pneumonia at week 15 Gastroenteritis, dehydrated, malaria at month 9
34NVPCardiohypertrophy, septicemia, urinary tract infection at week 6Febrile convulsions, bronchopneumonia week 6
36NVPPneumonia at month 15Diarrhea, failure to thrive, dehydration, poor nutrition, death at month 15
53ZDVParalytic ileus at week 11Malaria, septicemia, diarrhea, electrolyte imbalance
78ZDVOral thrush at month 7Diarrhea, anemia, death at month 7

From: 4, Efficacy and Safety

Cover of Review of the HIVNET 012 Perinatal HIV Prevention Study
Review of the HIVNET 012 Perinatal HIV Prevention Study.
Institute of Medicine (US) Committee on Reviewing the HIVNET 012 Perinatal HIV Prevention Study.
Washington (DC): National Academies Press (US); 2005.
Copyright © 2005, National Academy of Sciences.

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