Table 3

Frequency of new adverse effects in both groups after enrolment

Adverse effectAminophyllinePlaceboDifference
NewAbsent at baseline%NewAbsent at baseline%A − P %95% CIp value3-150
Nausea2944667312343(23 to 64)0.0004
Vomiting3552678421948(30 to 66)0.0001
Headache1562241567222(−13 to 16)0.84
Irritability2357402053383(−16 to 21)0.85
Tremor2740682034599(−13 to 31)0.48
Seizures180118210(−3 to 3)1.0
Any new1111100475743(6 to 80)0.04
  • Percentages are rounded to the nearest whole number.

  • 3-150 p value by Fisher’s exact test, two tailed.

  • A, aminophylline; P, placebo.