1 PFS |
3 |
|
Hazard Ratio (Random, 95% CI) |
Subtotals only |
1.1 TBD/PLD vs PLD |
1 |
672 |
Hazard Ratio (Random, 95% CI) |
0.79 [0.65, 0.96] |
1.2 CAN/PLD vs PLD |
1 |
125 |
Hazard Ratio (Random, 95% CI) |
0.92 [0.58, 1.46] |
1.3 EC145/PLD vs PLD |
1 |
149 |
Hazard Ratio (Random, 95% CI) |
0.63 [0.41, 0.97] |
2 PFS: PPS subgroup only |
1 |
|
Hazard Ratio (Random, 95% CI) |
Subtotals only |
2.1 PLD/TBD vs PLD |
1 |
208 |
Hazard Ratio (Random, 95% CI) |
0.65 [0.45, 0.93] |
3 OS |
3 |
|
Hazard Ratio (Random, 95% CI) |
Subtotals only |
3.1 TBD/PLD vs PLD |
1 |
|
Hazard Ratio (Random, 95% CI) |
0.86 [0.72, 1.02] |
3.2 CAN/PLD vs PLD |
1 |
|
Hazard Ratio (Random, 95% CI) |
0.0 [0.0, 0.0] |
3.3 EC145/PLD vs PLD |
1 |
|
Hazard Ratio (Random, 95% CI) |
1.01 [0.68, 1.50] |
4 SAE: Anaemia (G3/4) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
4.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
2.54 [1.45, 4.43] |
4.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
1.93 [0.71, 5.22] |
4.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
0.53 [0.22, 1.28] |
5 SAE: Neutropenia (G3/4) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
2.80 [2.25, 3.48] |
5.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
2.19 [1.05, 4.59] |
5.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.55, 2.08] |
6 SAE: Thrombocytopenia (G3/4) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
6.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
7.56 [3.67, 15.54] |
6.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
8.77 [1.16, 66.41] |
6.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
0.47 [0.12, 1.79] |
7 SAE: Vomiting (G3/4) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
4.81 [2.16, 10.70] |
7.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
1.46 [0.37, 5.85] |
7.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
0.06 [0.01, 0.45] |
8 SAE: HFS (G3) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
0.20 [0.11, 0.35] |
8.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
0.50 [0.15, 1.62] |
8.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
2.57 [0.59, 11.16] |
9 SAE: Stomatitis (G3/4) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.05, 0.59] |
9.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
0.70 [0.20, 2.49] |
9.3 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.30, 2.96] |
10 SAE: Alopecia (G2) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.60, 1.34] |
10.2 CAN/PLD vs PLD |
1 |
122 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
11 SAE: Abdominal pain (G3/4) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
1.87 [0.41, 8.48] |
12 SAE: Neuropathy (G3/4) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
1.40 [0.85, 2.31] |
12.2 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
4.25 [0.23, 77.45] |
13 SAE‐related death |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 TBD/PLD vs PLD |
1 |
663 |
Risk Ratio (M‐H, Random, 95% CI) |
2.48 [0.48, 12.68] |
13.2 EC145/PLD vs PLD |
1 |
157 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
14 Dose reductions |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
14.1 CAN/PLD vs PLD |
1 |
535 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.53, 2.14] |
15 Dose delays |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
15.1 CAN/PLD vs PLD |
1 |
535 |
Risk Ratio (M‐H, Random, 95% CI) |
1.50 [1.00, 2.26] |