TABLE 3.
Types and Frequencies of AE*
| Clinical Adverse Events | Laboratory Adverse Events | |||||||
|---|---|---|---|---|---|---|---|---|
|
|
|
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| Raltegravir Group N = 281 |
Efavirenz Group N = 282 |
Raltegravir Group N = 281 |
Efavirenz Group N = 282 |
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| Number of Participants | n (%) | n (%) | Δ† (95% CI) | P‡ | n (%) | n (%) | Δ† (95% CI) | P‡ |
| With one or more AE | 266 (95) | 275 (98) | −3 (−6 to 0.4) | 0.086 | 36 (13) | 59 (21) | −8 (−14 to −1.9) | 0.013 |
| With drug-related AE§ | 132 (47) | 220 (78) | −31 (−38 to −23) | <0.001 | 19 (7) | 35 (12) | −6 (−11 to −1) | 0.031 |
| With serious AE‖ | 40 (14) | 34 (12) | 2 (−4 to 8) | 0.457 | 0 (0) | 2 (1) | −1 (−3 to 1) | 0.499 |
| With serious drug-related AE§ | 6 (2) | 5 (2) | 0.4 (−2 to 3) | 0.772 | 0 (0) | 12 (0.4) | −0.4 (−2 to 1) | 1.000 |
| Who discontinued due to AE¶ | 11 (4) | 17 (6) | −2 (−6 to 2) | 0.333 | 0 (0) | 3 (1) | −1 (−3 to 0.3) | 0.249 |
| Who discontinued due to drug-related AE§ | 3 (1) | 12 (4) | −3 (−6 to −1) | ND | 0 (0) | 2 (7) | −0.7 (−3 to 0.7) | ND |
| Who discontinued due to serious AE | 9 (3) | 5 (2) | 1 (−1 to 4) | ND | 0 (0) | 1 (0.4) | −0.4 (−2 to 1) | ND |
| Who discontinued due to serious drug-related AE§ | 1 (0.4) | 2 (0.7) | −0.4 (−2.2 to 1.3) | ND | 0 (0) | 1 (0.4) | −0.4 (−2 to 1) | ND |
All treated patients were included in the safety analysis. All adverse events occurring during the study or within 14 days of study discontinuation through May 6, 2009 (the day when the last patient remaining in the study had their 96-week assessment) were counted. The frequencies of adverse events were not adjusted for the duration of follow-up.
Difference (Δ) and 95% CI was calculated as the response rate in the raltegravir group minus the response rate in the efavirenz group. The 95% CIs were calculated using the method of Miettinen and Nurminen.15
Tests of significance were performed on the percentage of patients with at least one adverse experience in a prespecified category per protocol. P-values were generated using the Fisher exact test.
Determined by investigator to be possibly, probably, or definitely drug-related to any drug in the study regimen.
Three patients in the raltegravir group died; none of which was judged to be drug-related.
The discontinuations in the table refer to discontinuation of study medications (even if the patient remained in the study), whereas Figure 1 describes study discontinuations. The discordance between table and figure arises from patients who stopped study medication due to an adverse event but remained on study at the time of the Week 96 analysis.
N, Number of patients in each group; n (%) = number (percent) of patients in each category; ND, not done (because the test was not prespecified in the data analysis plan).
AE, adverse event.