Table 2.
Outcomes at 1-year follow-up
| Variable | Restrictive-fluid group (n = 767) | Standard-fluid group (n = 782) | Adjusted risk difference or adjusted mean difference (99% CI) | Adjusted relative risk or adjusted ratio of means (99% CI) | P valuea | Missing values |
|---|---|---|---|---|---|---|
| Mortality | ||||||
| Death by 1 year | 385 (51.3%) | 383 (49.9%) | 1.5% (− 4.8% to 7.8%) | 1.03 (0.91–1.17) | 0.55 | 32 (2.1%) |
| Health-related quality of life | ||||||
| EQ-5D-5L index valuesb | 0 (0–0.82) | 0 (0–0.81) | 0 (− 0.06 to 0.05) | 0.99 (0.85–1.16) | 0.81 | 135 (8.7%) |
| Survivors onlyc | 0.83 (0.58–0.93) | 0.81 (0.58–0.93) | 0.01 (− 0.05 to 0.07) | 1.01 (0.93–1.1) | 0.61 | 102 (13.6%) |
| EQ VAS | 0 (0–70) | 0 (0–70) | − 0.65 (− 5.4 to 4.08) | 0.98 (0.84–1.14) | 0.80 | 140 (9%) |
| Survivors onlyc | 70 (50–80) | 70 (50–80) | − 0.05 (− 5.29 to 5.25) | 1 (0.92–1.09) | 0.63 | 108 (14.4%) |
| Cognitive testd | ||||||
| Mini MoCA | 0 (0–22) | 0 (0–22) | − 0.14 (− 1.59 to 1.31) | 0.99 (0.86–1.14) | 0.82 | 212 (13.7%) |
| Survivors onlyc | 22 (17.5–25) | 22 (18–24.5) | 0.16 (− 0.96 to 1.39) | 1.01 (0.95–1.07) | 0.59 | 180 (24%) |
CI confidence interval, EQ-5D-5L: EuroQol 5 domains 5 levels, VAS visual analogue scale, MoCA Montreal cognitive assessment
Numeric data are presented as medians with interquartile ranges, and categorical data as numbers and percentages
The analysis population consisted of all randomized patients except 5, who withdrew consent for the use of all data (n = 1549). Patients with missing values include patients lost to follow-up and patients who withdraw consent (n = 43)
aAll analyses were adjusted for the stratification variables, which were trial site and hematologic or metastatic cancer at baseline. Results are presented as adjusted, unconditional, average treatment effects
bIndex values calculated using country-specific value sets, as described in the Methods section
cPost hoc analyses
dNonsurvivors at 1 year after randomization were assigned the value zero corresponding to a health state as bad as being dead for EQ-5D-5L index values and the worst possible score for EQ VAS and Mini MoCA. Missing data were multiply imputed and all HRQoL and cognitive function results in this table (including descriptive data) were calculated using the multiply imputed datasets. We collected data for EQ-5D-5L index values for 1,414 (91.3%) patients, for EQ VAS scores for 1,409 (91%) patients, and for Mini MoCA for 1,337 (86.3%) patients