Table 3

Adverse events and other safety markers in the CAPRISA 004 tenofovir gel trial.

Tenofovir gelPlacebo gelP value
Events/participants/(percent with ≥ 1 event)Events/participants/(percent with ≥ 1 event)
Number of adverse events2419/423/(95.1)2273/415/(93.5)0.32
Deaths0/0/(0)1/1/(0.2)0.50
Serious adverse events:
   total serious adverse events
23/21/(4.7)16/16/(3.6)0.50
      Pregnancy-related serious adverse events8/8/(1.8)8/8/(1.8)1.00
      Grade 3* adverse events19/15/(3.4)18/16/(3.6)0.86
      Grade 4* adverse events4/4/(0.9)4/3/(0.7)1.00
Common adverse events
   Influenza365/216/(48.5)314/220/(49.5)0.79
   Vaginal discharge203/156/(35.1)239/156/(35.1)1.00
   Headache126/93/(20.9)133/102/(23.0)0.53
   Urinary tract infection135/100/(22.5)120/93/(20.9)0.63
   Diarrhea and gastrointestinal infections91/75/(16.9)65/49/(11.0)0.02
   Upper respiratory tract infections162/114/(25.6)145/100/(22.5)0.31
Genital adverse events
Disrupted epithelium, e.g., genital ulceration18/18/(4.0)14/13/(2.9)0.47
   Intact epithelium, e.g., erythema48/41/(9.2)42/33/(7.4)0.40
   Urogenital symptoms (such as menorrhagia)312/210/(47.2)394/238/(53.6)0.06
   Vaginal candidiasis156/114/(25.6)187/130/(29.3)0.23
   Other182/131/(29.4)176/123/(27.7)0.60
Laboratory parameters: any abnormality after randomization
   Hepatic
      Aspartate aminotransferase (AST)29/21/(4.7)36/29/(6.5)0.25
      Alanine transaminase (ALT)42/33/(7.4)50/40/(9.0)0.38
   Renal
      Raised creatinine3/3/(0.7)1/1/(0.2)0.62
      Low potassium119/95/(21.3)99/83/(18.7)0.36
      Abnormal sodium54/48/(10.8)43/41/(9.2)0.50
   Hematological
      Anemia52/34/(7.6)46/29/(6.5)0.60
      Neutropenia19/16/(3.6)13/11/(2.5)0.44
   Bone
      Low phosphate79/62/(13.9)65/51/(11.5)0.31
      Abnormal calcium16/15/(3.4)14/13/(2.9)0.85
      Fractures5/4/(0.9)2/2/(0.5)0.69
Pregnancy rate per 100 women-years3.24.70.18
Proportion of pregnancies resulting in live births66.751.90.38

*Grade 3 and 4 adverse events refer to the grading for severity according to the Division of AIDS Table for Grading Adult and Pediatric Adverse Events, 2004 (http://rsc.tech-res.com/safetyandpharmacovigilance/).