Table 1.

Trial characteristics

Trial	099–14	CP-043	FEN-201	INS-05–001
Primary publication	Portenoy, 2006	Portenoy, 2010	Rauck, 2010	Rauck 2012
DESIGN FEATURES
Response definition for enrollment	At least 2 consecutive episodes at a particular dose yielded satisfactory pain relief without unacceptable AEs	At least 2 consecutive episodes at a particular dose yielded acceptable pain relief without unacceptable AEs	At least 2 episodes at a particular dose yielded satisfactory pain relief	At least 2 consecutive episodes at a particular dose yielded acceptable pain relief without unacceptable AEs
Episodes	7 active, 3 placebo	7 active, 3 placebo	6 active, 3 placebo	7 active, 3 placebo
SPID calculation	(0–15)*15+(0–30)*15	(0–5)*5+(0–10)*5+ (0–15)*5+(0–30)*15	(0–5)*5+(0–10)*5+ (0–15)*5+(0–30)*15	(0–5)*5+(0–10)*5+ (0–15)*5+(0–30)*15
Restrictions on sequence order	1 of 18 possible sequences; the first episode could not be placebo and 2 consecutive episodes could not be placebo	Not indicated in paper or study report synopsis	2 consecutive episodes could not be placebo	Not indicated in paper or study report synopsis
RESULTS
Number of participants enrolled in the dose-titration phase	123	114	151	130
Number of participants randomized	77	83	82	98
Number of participants who provided data for all 10 (9) episodes	61	48	46	81
Number of participants who provided post-treatment data for at least 1 active and 1 placebo episode (included in the analyses)	72	73	75	93
Number of active episodes with data from at least 1 post-treatment time point	490	459	392	635
Number of placebo episodes with data from at least 1 post-treatment time point	206	200	196	269

AE: adverse event; SPID: summed pain intensity difference

^*Numbers within parentheses for the SPIC calculation refer to the pain score at that time in minutes post dose. Thus, for example, (0–15) represents the pain score at the time of the dose of medication minus the pain score 15 minutes after the dose of medication.