| AESI category, n (%) PT . | Fruquintinib + BSC (n = 456) . | Placebo + BSC (n = 230) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥ 3 . | Any grade . | Grade ≥ 3 . | |
| Hypertension* | 139 (30.5) | 51 (11.2) | 12 (5.2) | 2 (0.9) |
| Hypertension | 132 (28.9) | 49 (10.7) | 12 (5.2) | 2 (0.9) |
| Dermatological toxicity | 129 (28.3) | 29 (6.4) | 17 (7.4) | 0 |
| PPE syndrome | 85 (18.6) | 28 (6.1) | 6 (2.6) | 0 |
| Hepatic function abnormal | 46 (10.1) | 12 (2.6) | 9 (3.9) | 3 (1.3) |
| AST increased | 24 (5.3) | 2 (0.4) | 2 (0.9) | 1 (0.4) |
| ALT increased | 22 (4.8) | 5 (1.1) | 1 (0.4) | 0 |
| Blood bilirubin increased | 12 (2.6) | 1 (0.2) | 1 (0.4) | 0 |
| Thyroid dysfunction | 87 (19.1) | 2 (0.4) | 3 (1.3) | 0 |
| Hypothyroidism | 71 (15.6) | 2 (0.4) | 1 (0.4) | 0 |
| Blood thyroid stimulating hormone increased | 18 (3.9) | 0 | 2 (0.9) | 0 |
| Infection | 11 (2.4) | 2 (0.4) | 2 (0.9) | 0 |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Hemorrhages | 33 (7.2) | 3 (0.7) | 5 (2.2) | 0 |
| Embolic and thrombotic events | 7 (1.5) | 6 (1.3) | 1 (0.4) | 1 (0.4) |
| Gastrointestinal perforation | 6 (1.3) | 6 (1.3) | 0 | 0 |
| Left ventricular ejection fraction decreased | 3 (0.7) | 2 (0.4) | 3 (1.3) | 0 |
| AESI category, n (%) PT . | Fruquintinib + BSC (n = 456) . | Placebo + BSC (n = 230) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥ 3 . | Any grade . | Grade ≥ 3 . | |
| Hypertension* | 139 (30.5) | 51 (11.2) | 12 (5.2) | 2 (0.9) |
| Hypertension | 132 (28.9) | 49 (10.7) | 12 (5.2) | 2 (0.9) |
| Dermatological toxicity | 129 (28.3) | 29 (6.4) | 17 (7.4) | 0 |
| PPE syndrome | 85 (18.6) | 28 (6.1) | 6 (2.6) | 0 |
| Hepatic function abnormal | 46 (10.1) | 12 (2.6) | 9 (3.9) | 3 (1.3) |
| AST increased | 24 (5.3) | 2 (0.4) | 2 (0.9) | 1 (0.4) |
| ALT increased | 22 (4.8) | 5 (1.1) | 1 (0.4) | 0 |
| Blood bilirubin increased | 12 (2.6) | 1 (0.2) | 1 (0.4) | 0 |
| Thyroid dysfunction | 87 (19.1) | 2 (0.4) | 3 (1.3) | 0 |
| Hypothyroidism | 71 (15.6) | 2 (0.4) | 1 (0.4) | 0 |
| Blood thyroid stimulating hormone increased | 18 (3.9) | 0 | 2 (0.9) | 0 |
| Infection | 11 (2.4) | 2 (0.4) | 2 (0.9) | 0 |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Hemorrhages | 33 (7.2) | 3 (0.7) | 5 (2.2) | 0 |
| Embolic and thrombotic events | 7 (1.5) | 6 (1.3) | 1 (0.4) | 1 (0.4) |
| Gastrointestinal perforation | 6 (1.3) | 6 (1.3) | 0 | 0 |
| Left ventricular ejection fraction decreased | 3 (0.7) | 2 (0.4) | 3 (1.3) | 0 |
*Includes hypertension, hypertensive crisis, increased diastolic blood pressure, increased blood pressure and hypertensive retinopathy.
Abbreviations: AESI, adverse event of specific interest; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSC, best supportive care; PPE, palmar-plantar erythrodysesthesia; PT, preferred term.
| AESI category, n (%) PT . | Fruquintinib + BSC (n = 456) . | Placebo + BSC (n = 230) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥ 3 . | Any grade . | Grade ≥ 3 . | |
| Hypertension* | 139 (30.5) | 51 (11.2) | 12 (5.2) | 2 (0.9) |
| Hypertension | 132 (28.9) | 49 (10.7) | 12 (5.2) | 2 (0.9) |
| Dermatological toxicity | 129 (28.3) | 29 (6.4) | 17 (7.4) | 0 |
| PPE syndrome | 85 (18.6) | 28 (6.1) | 6 (2.6) | 0 |
| Hepatic function abnormal | 46 (10.1) | 12 (2.6) | 9 (3.9) | 3 (1.3) |
| AST increased | 24 (5.3) | 2 (0.4) | 2 (0.9) | 1 (0.4) |
| ALT increased | 22 (4.8) | 5 (1.1) | 1 (0.4) | 0 |
| Blood bilirubin increased | 12 (2.6) | 1 (0.2) | 1 (0.4) | 0 |
| Thyroid dysfunction | 87 (19.1) | 2 (0.4) | 3 (1.3) | 0 |
| Hypothyroidism | 71 (15.6) | 2 (0.4) | 1 (0.4) | 0 |
| Blood thyroid stimulating hormone increased | 18 (3.9) | 0 | 2 (0.9) | 0 |
| Infection | 11 (2.4) | 2 (0.4) | 2 (0.9) | 0 |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Hemorrhages | 33 (7.2) | 3 (0.7) | 5 (2.2) | 0 |
| Embolic and thrombotic events | 7 (1.5) | 6 (1.3) | 1 (0.4) | 1 (0.4) |
| Gastrointestinal perforation | 6 (1.3) | 6 (1.3) | 0 | 0 |
| Left ventricular ejection fraction decreased | 3 (0.7) | 2 (0.4) | 3 (1.3) | 0 |
| AESI category, n (%) PT . | Fruquintinib + BSC (n = 456) . | Placebo + BSC (n = 230) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥ 3 . | Any grade . | Grade ≥ 3 . | |
| Hypertension* | 139 (30.5) | 51 (11.2) | 12 (5.2) | 2 (0.9) |
| Hypertension | 132 (28.9) | 49 (10.7) | 12 (5.2) | 2 (0.9) |
| Dermatological toxicity | 129 (28.3) | 29 (6.4) | 17 (7.4) | 0 |
| PPE syndrome | 85 (18.6) | 28 (6.1) | 6 (2.6) | 0 |
| Hepatic function abnormal | 46 (10.1) | 12 (2.6) | 9 (3.9) | 3 (1.3) |
| AST increased | 24 (5.3) | 2 (0.4) | 2 (0.9) | 1 (0.4) |
| ALT increased | 22 (4.8) | 5 (1.1) | 1 (0.4) | 0 |
| Blood bilirubin increased | 12 (2.6) | 1 (0.2) | 1 (0.4) | 0 |
| Thyroid dysfunction | 87 (19.1) | 2 (0.4) | 3 (1.3) | 0 |
| Hypothyroidism | 71 (15.6) | 2 (0.4) | 1 (0.4) | 0 |
| Blood thyroid stimulating hormone increased | 18 (3.9) | 0 | 2 (0.9) | 0 |
| Infection | 11 (2.4) | 2 (0.4) | 2 (0.9) | 0 |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Proteinuria | 63 (13.8) | 7 (1.5) | 8 (3.5) | 1 (0.4) |
| Hemorrhages | 33 (7.2) | 3 (0.7) | 5 (2.2) | 0 |
| Embolic and thrombotic events | 7 (1.5) | 6 (1.3) | 1 (0.4) | 1 (0.4) |
| Gastrointestinal perforation | 6 (1.3) | 6 (1.3) | 0 | 0 |
| Left ventricular ejection fraction decreased | 3 (0.7) | 2 (0.4) | 3 (1.3) | 0 |
*Includes hypertension, hypertensive crisis, increased diastolic blood pressure, increased blood pressure and hypertensive retinopathy.
Abbreviations: AESI, adverse event of specific interest; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSC, best supportive care; PPE, palmar-plantar erythrodysesthesia; PT, preferred term.
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