Summary of Results
| . | Subgroup 1: Intent to Treat (n = 49) . | Subgroup 2: Excludes Patients With Study Drug Infusion Time <24 Hours (n = 45) . | Subgroup 3: Excludes Patients Who Did Not Receive Full Dose of Study Drug < 48 h (n = 31) . |
|---|---|---|---|
| Duration of painful episodes3-150 | |||
| RheothRx | 67 h | 60 h | 44 h |
| (r = 12-178) | (r = 12-178) | (r = 12-168) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Placebo | 80 h | 88 h | 80 h |
| (r = 12-315) | (r = 12-315) | (r = 12-315) | |
| (n = 22) | (n = 20) | (n = 13) | |
| RheothRx v placebo | −16% | −32% | −45% |
| Unadjusted P value3-151 | 0.147 | 0.097 | 0.020 |
| Adjusted P value3-152 | 0.182 | 0.122 | 0.025 |
| Duration of hospitalizationρ | |||
| RheothRx | 5 d | 5 d | 5 d |
| (r = 4-11) | (r = 4-11) | (r = 4-9) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Placebo | 6 d | 7 d | 7 d |
| (r = 3-14) | (r = 3-14) | (r = 4-14) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.298 | 0.261 | 0.145 |
| Adjusted P value3-152 | 0.258 | 0.202 | 0.111 |
| Total analgesic use3-155 | |||
| All analgesics | |||
| Median MEU | |||
| RheothRx | 57 mg | 49 mg | 34 mg |
| (r = 0-520) | (r = 0-520) | (r = 0-207) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Median MEU | |||
| Placebo | 159 mg | 169 mg | 145 mg |
| (r = 2-456) | (r = 2-456) | (r = 2-456) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.055 | 0.037 | 0.014 |
| Adjusted P value3-152 | 0.200 | 0.144 | 0.045 |
| Parenterals only | |||
| Median MEU | |||
| RheothRx | 47 mg | 40 mg | 27 mg |
| (r = 0-490) | (r = 0-490) | (r = 0-170) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Median MEU | |||
| Placebo | 149 mg | 150 mg | 133 mg |
| (r = 0-390) | (r = 0-390) | (r = 0-390) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.075 | 0.048 | 0.014 |
| Adjusted P value3-152 | 0.220 | 0.130 | 0.022 |
| . | Subgroup 1: Intent to Treat (n = 49) . | Subgroup 2: Excludes Patients With Study Drug Infusion Time <24 Hours (n = 45) . | Subgroup 3: Excludes Patients Who Did Not Receive Full Dose of Study Drug < 48 h (n = 31) . |
|---|---|---|---|
| Duration of painful episodes3-150 | |||
| RheothRx | 67 h | 60 h | 44 h |
| (r = 12-178) | (r = 12-178) | (r = 12-168) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Placebo | 80 h | 88 h | 80 h |
| (r = 12-315) | (r = 12-315) | (r = 12-315) | |
| (n = 22) | (n = 20) | (n = 13) | |
| RheothRx v placebo | −16% | −32% | −45% |
| Unadjusted P value3-151 | 0.147 | 0.097 | 0.020 |
| Adjusted P value3-152 | 0.182 | 0.122 | 0.025 |
| Duration of hospitalizationρ | |||
| RheothRx | 5 d | 5 d | 5 d |
| (r = 4-11) | (r = 4-11) | (r = 4-9) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Placebo | 6 d | 7 d | 7 d |
| (r = 3-14) | (r = 3-14) | (r = 4-14) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.298 | 0.261 | 0.145 |
| Adjusted P value3-152 | 0.258 | 0.202 | 0.111 |
| Total analgesic use3-155 | |||
| All analgesics | |||
| Median MEU | |||
| RheothRx | 57 mg | 49 mg | 34 mg |
| (r = 0-520) | (r = 0-520) | (r = 0-207) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Median MEU | |||
| Placebo | 159 mg | 169 mg | 145 mg |
| (r = 2-456) | (r = 2-456) | (r = 2-456) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.055 | 0.037 | 0.014 |
| Adjusted P value3-152 | 0.200 | 0.144 | 0.045 |
| Parenterals only | |||
| Median MEU | |||
| RheothRx | 47 mg | 40 mg | 27 mg |
| (r = 0-490) | (r = 0-490) | (r = 0-170) | |
| (n = 27) | (n = 25) | (n = 18) | |
| Median MEU | |||
| Placebo | 149 mg | 150 mg | 133 mg |
| (r = 0-390) | (r = 0-390) | (r = 0-390) | |
| (n = 22) | (n = 20) | (n = 13) | |
| Unadjusted P value3-151 | 0.075 | 0.048 | 0.014 |
| Adjusted P value3-152 | 0.220 | 0.130 | 0.022 |
Abbreviation: r, range.
Values reported represent the median number of hours of the painful episode. Duration of painful episode is defined as the time from initiation of study drug until the two criteria for termination are met: End of painful event is the end of an 8-hour period of no pain, residual pain, or mild pain and 2) at least 12 hours after the administration of parenteral analgesics.
Log-Rank test.
Proportional hazards model adjusted for baseline pain.
ρ Values reported represent the median number of days in hospital. A 3-day minimum stay was required.
Values reported represent the amount of analgesics administered in morphine equivalent units (MEU).