Table 3.

Post Hoc Analysis: Flares

Flares	POF	95% Confidence Interval
A. Flares (Entire Study)
Relative Risk Reduction	0.549	(0.21, 0.89)
Absolute Risk Reduction	0.506	(0.22, 0.80)
Number Needed to Treat	2	(1.26, 4.61)
B. Flares (For subjects participating > 6 months)
Relative Risk Reduction	0.667	(0.36, 0.97)
Absolute Risk Reduction	0.667	(0.36, 0.97)
Number Needed to Treat	2	(1.03, 2.79)
C. Flares (Worst Case Scenario, drop outs up to 6 months)
Relative Risk Reduction	0.462	(0.08, 0.84)
Absolute Risk Reduction	0.396	(0.11, 0.68)
Number Needed to Treat	3	(1.46, 9.31)
D. Flares (Worst Case Scenario, drop outs up to 9 months)
Relative Risk Reduction	0.192	(−0.17, 0.55)
Absolute Risk Reduction	0.165	(−0.10, 0.43)
Number Needed to Treat	6	(2.31, infinity)

Determination of the relative risk reduction (RRR), absolute risk reduction (ARR), and number needed to treat (NNT) (50), with pentoxifylline (POF), was performed for pulmonary sarcoid flares. (A) The analysis of flares for the “entire study period”, included evaluable subjects who were in the trial for less than six months. Flare risk analysis was then restricted to subjects participating at least 6 months or more (B). Thereafter, an intention-to-treat,worst case scenario method (51) was applied. In this method, drop outs and removed subjects in the POF arm, without a documented flare, were allocated as if they had developed a “theoretical” flare; drop outs and removed subjects in the placebo arm, who had not flared, were ascribed to a non-flare state. The worst case scenario risk analysis was confined to subject drop outs and removals that occurred up to 6 (C) and 9 (D) months, respectively. The four groups of post hoc flare analyses are shown above.