TABLE 4.
Unexpected medical visit and potential side effects counts by region: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial
| Variable | Int P value | Total (n=11,879) | Africa (n=3735) | India (n=4818) | Pakistan (n=1625) | Guatemala (n=1701) |
|---|---|---|---|---|---|---|
| Number of unexpected emergency medical visit, RR (95% CI) | .785 | 0.96 (0.89–1.04) | 1.01 (0.88–1.16) | 0.99 (0.93–1.04) | 0.94 (0.84–1.06) | 0.91 (0.70–1.18) |
| Aspirin | 1 (1–2) | 1 (1–1) | 2 (1–3) | 1 (1–2) | 1 (1–1) | |
| Placebo | 1 (1–2) | 1 (1–1) | 2 (1–3) | 1 (1–2) | 1 (1–1) | |
| Biweekly monitoring of potential side effects | ||||||
| Number of potential side effects, RR (95% CI) | .003 | 0.96 (0.93–0.99) | 0.98 (0.91 −1.06) | 1.01 (0.98–1.04) | 0.92 (0.87–0.96) | 0.93 (0.85–1.02) |
| Aspirin | 3 (1–7) | 2 (1–3) | 4 (2–8) | 4 (2–8) | 2 (1–3) | |
| Placebo | 3 (1–6) | 2 (1–3) | 4 (2–8) | 4 (2–9) | 2 (1–4) | |
| Number of episodes of nausea, RR (95% CI) | .092 | 0.99 (0.93–1.05) | 1.04 (0.90–1.20) | 1.06 (0.99–1.12) | 0.95 (0.88–1.02) | 0.90 (0.76–1.08) |
| Aspirin | 2 (1–3) | 1 (1–2) | 2 (1–3) | 2 (1–4) | 1 (1–2) | |
| Placebo | 2 (1–3) | 1 (1–2) | 2 (1–3) | 2 (1–4) | 1 (1–2) | |
| Number of episodes of vomiting, RR (95% CI) | .192 | 0.98 (0.91 −1.06) | 1.09 (0.93–1.28) | 1.01 (0.96–1.08) | 0.93 (0.85–1.01) | 0.91 (0.72–1.16) |
| Aspirin | 2 (1–3) | 1 (1–2) | 2 (1–3) | 2 (1–3) | 1 (1–2) | |
| Placebo | 2 (1–3) | 1 (1–2) | 2 (1–3) | 2 (1–4) | 1 (1–2) | |
| Number of episodes of rash or hives, RR (95% CI) | .841 | 1.00 (0.83–1.21) | 0.98 (0.60–1.60) | 0.97 (0.73–1.29) | 0.91 (0.73–1.14) | 1.15 (0.74–1.79) |
| Aspirin | 1 (1–2) | 1 (1–1) | 1 (1–1) | 1 (1–2) | 1 (1–2) | |
| Placebo | 1 (1–2) | 1 (1–1) | 1 (1–1) | 1 (1–2) | 1 (1–2) | |
| Number of episodes of diarrhea, RR (95% CI) | .902 | 0.96 (0.83–1.10) | 0.94 (0.71 −1.23) | 0.91 (0.78–1.06) | 0.95 (0.68–1.34) | 1.04 (0.76–1.40) |
| Aspirin | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | |
| Placebo | 1 (1–1) | 1 (1–1) | 1 (1–2) | 1 (1–1) | 1 (1–1) | |
| Number of episodes of gastritis, RR (95% CI) | .840 | 0.97 (0.89–1.05) | 0.94 (0.75–1.18) | 0.99 (0.90–1.09) | 0.93 (0.81–1.06) | 1.01 (0.83–1.23) |
| Aspirin | 1 (1–2) | 1 (1–1) | 1 (1–2) | 1 (1–2) | 1 (1–3) | |
| Placebo | 1 (1–2) | 1 (1–1) | 1 (1–2) | 1 (1–2) | 1 (1–2) | |
| Number of episodes of vaginal bleeding, RR (95% CI) | .599 | 1.02 (0.84–1.24) | 1.08 (0.74–1.57) | 0.93 (0.71 −1.22) | 1.23 (0.86–1.75) | 0.88 (0.54–1.45) |
| Aspirin | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | |
| Placebo | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | |
| Number of episodes of allergic reaction, RR (95% CI) | .945 | 1.04 (0.50–2.16) | 0.94 (0.36–2.45) | 0.85 (0.32–2.24) | 1.12 (0.10–12.41) | 1.29 (0.48–3.45) |
| Aspirin | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) | |
| Placebo | 1 (1–1) | 1 (1–2) | 1 (1–2) | 1 (1–1) | 1 (1–1) | |
| Number of episodes of other potential side effect, RR (95% CI) | .080 | 0.95 (0.88–1.04) | 0.95 (0.83–1.09) | 1.03 (0.97–1.08) | 0.87 (0.77–0.98) | 0.98 (0.76–1.28) |
| Aspirin | 2 (1–3) | 1 (1–2) | 2 (1–4) | 1 (1–2) | 1 (1–1) | |
| Placebo | 2 (1–3) | 1 (1–2) | 2 (1–3) | 1 (1–3) | 1 (1–2) | |
Data are presented as median (25th percentile–75th percentile), unless otherwise specified. Unexpected emergency medical visits may have been related to potential side effects but are analyzed separately from potential side effects reported at biweekly visits. The denominator is any participant included in the safety population who experienced at least 1 episode of that specific event, and the numerator is the number of events of that specific type experienced by the participant. In addition, the RR models have been adjusted for the number of biweekly visits completed (range, 1–16). The most commonly reported other potential side effects include cold/cough or fever, abdominal pain or discomfort, and headache.
CI, confidence interval; Int, interaction; RR, relative risk.
Short. Aspirin safety during pregnancy in low- and middle-income countries. Am J Obstet Gynecol Glob Rep 2021.