Table 1.
Study JVDB: treatment-emergent adverse events and serious adverse events.
| TEAEs (All-Grade) Reported in ≥10% of Patients by MedDRA Preferred Term a | Number (%) of Patients (JVDB) | ||||
|---|---|---|---|---|---|
| Arm 1 8 mg/kg Q2W N = 38 |
Arm 2 12 mg/kg Q2W N = 42 |
Arm 3 6 mg/kg QW N = 41 |
Arm 4 8 mg/kg D1D8-Q3W N = 40 |
Total N = 161 |
|
| Patients with ≥1 TEAE | 31 (81.6) | 32 (76.2) | 36 (87.8) | 32 (80.0) | 131 (81.4) |
| Fatigue | 9 (23.7) | 15 (35.7) | 10 (24.4) | 12 (30.0) | 46 (28.6) |
| Decreased appetite | 8 (21.1) | 9 (21.4) | 11 (26.8) | 6 (15.0) | 34 (21.1) |
| Abdominal pain | 7 (18.4) | 12 (28.6) | 9 (22.0) | 6 (15.0) | 34 (21.1) |
| Vomiting | 7 (18.4) | 7 (16.7) | 7 (17.1) | 8 (20.0) | 29 (18.0) |
| Nausea | 6 (15.8) | 4 (9.5) | 4 (9.8) | 6 (15.0) | 20 (12.4) |
| Aspartate aminotransferase increased | 5 (13.2) | 5 (11.9) | 2 (4.9) | 0 (0.0) | 12 (7.5) |
| Hypertension | 5 (13.2) | 2 (4.8) | 7 (17.1) | 5 (12.5) | 19 (11.8) |
| Pyrexia | 5 (13.2) | 2 (4.8) | 4 (9.8) | 1 (2.5) | 12 (7.5) |
| Anemia | 4 (10.5) | 5 (11.9) | 5 (12.2) | 2 (5.0) | 16 (9.9) |
| Dyspnea | 4 (10.5) | 4 (9.5) | 2 (4.9) | 4 (10.0) | 14 (8.7) |
| Headache | 4 (10.5) | 5 (11.9) | 5 (12.2) | 3 (7.5) | 17 (10.6) |
| Hypoalbuminemia | 4 (10.5) | 2 (4.8) | 3 (7.3) | 0 | 9 (5.6) |
| Proteinuria | 4 (10.5) | 1 (2.4) | 2 (4.9) | 2 (5.0) | 9 (5.6) |
| Alanine aminotransferase increased | 3 (7.9) | 5 (11.9) | 0 | 0 | 8 (5.0) |
| Diarrhea | 3 (7.9) | 10 (23.8) | 3 (7.3) | 5 (12.5) | 21 (13.0) |
| Constipation | 2 (5.3) | 6 (14.3) | 7 (17.1) | 7 (17.5) | 22 (13.7) |
| Epistaxis | 1 (2.6) | 1 (2.4) | 5 (12.2) | 2 (5.0) | 9 (5.6) |
| Dyspepsia | 0 | 1 (2.4) | 0 | 4 (10.0) | 5 (3.1) |
| TEAEs (Grade ≥3) reported in ≥5% of patients by MedDRA Preferred Term a |
Arm 1
8 mg/kg Q2W N = 38 |
Arm 2
12 mg/kg Q2W N = 42 |
Arm 3
6 mg/kg QW N = 41 |
Arm 4
8 mg/kg D1D8-Q3W N = 40 |
Total
N = 161 |
| Patients with ≥1 grade ≥3 TEAE | 14 (36.8) | 18 (42.9) | 18 (43.9) | 16 (40.0) | 66 (41.0) |
| Decreased appetite | 3 (7.9) | 0 | 0 | 0 | 3 (1.9) |
| Hypertension | 3 (7.9) | 1 (2.4) | 2 (4.9) | 2 (5.0) | 8 (5.0) |
| Abdominal pain | 3 (7.9) | 2 (4.8) | 2 (4.9) | 3 (7.5) | 10 (6.2) |
| Anemia | 2 (5.3) | 2 (4.8) | 2 (4.9) | 1 (2.5) | 7 (4.3) |
| Blood alkaline phosphatase increased | 2 (5.3) | 1 (2.4) | 0 | 0 | 3 (1.9) |
| Muscular weakness | 2 (5.3) | 0 | 1 (2.4) | 0 | 3 (1.9) |
| Pneumothorax | 2 (5.3) | 0 | 0 | 0 | 2 (1.2) |
| Pyrexia | 2 (5.3) | 0 | 0 | 0 | 2 (1.2) |
| Fatigue | 1 (2.6) | 6 (14.3) | 1 (2.4) | 3 (7.5) | 11 (6.8) |
| Vomiting | 1 (2.6) | 2 (4.8) | 0 | 3 (7.5) | 6 (3.7) |
| Back pain | 0 | 0 | 2 (4.9) | 2 (5.0) | 4 (2.5) |
| SAEs reported in ≥2 patients by MedDRA Preferred Term a |
Arm 1
8 mg/kg Q2W N = 38 |
Arm 2
12 mg/kg Q2W N = 42 |
Arm 3
6 mg/kg QW N = 41 |
Arm 4
8 mg/kg D1D8-Q3W N = 40 |
Total
N = 161 |
| Patients with ≥1 SAE | 10 (26.3) | 9 (21.4) | 10 (24.4) | 14 (35.0) | 43 (26.7) |
| Non-cardiac chest pain | 2 (5.3) | 0 | 0 | 0 | 2 (1.2) |
| Pyrexia | 2 (5.3) | 0 | 0 | 0 | 2 (1.2) |
| Vomiting | 1 (2.6) | 1 (2.4) | 0 | 3 (7.5) | 5 (3.1) |
| Abdominal pain | 1 (2.6) | 1 (2.4) | 0 | 2 (5.0) | 4 (2.5) |
| Back pain | 1 (2.6) | 0 | 1 (2.4) | 1 (2.5) | 3 (1.9) |
| Cardiac arrest | 1 (2.6) | 1 (2.4) | 0 | 0 | 2 (1.2) |
| Device related infection | 1 (2.6) | 1 (2.4) | 0 | 0 | 2 (1.2) |
| Pneumothorax | 1 (2.6) | 0 | 0 | 1 (2.5) | 2 (1.2) |
| Dysphagia | 0 | 1 (2.4) | 1 (2.4) | 1 (2.5) | 3 (1.9) |
| Gastric hemorrhage | 0 | 0 | 3 (7.3) b | 0 | 3 (1.9) |
| Pneumonia | 0 | 2 (4.8) | 0 | 1 (2.5) | 3 (1.9) |
| Anemia | 0 | 1 (2.4) | 0 | 1 (2.5) | 2 (1.2) |
| Dyspnea | 0 | 1 (2.4) | 1 (2.4) | 0 | 2 (1.2) |
| Gastrointestinal hemorrhage | 0 | 0 | 1 (2.4) | 1 (2.5) | 2 (1.2) |
| Hematemesis | 0 | 0 | 1 (2.4) | 1 (2.5) | 2 (1.2) |
| Hemoptysis | 0 | 0 | 1 (2.4) | 1 (2.5) | 2 (1.2) |
| Pulmonary embolism | 0 | 1 (2.4) | 0 | 1 (2.5) | 2 (1.2) |
| Respiratory failure | 0 | 0 | 1 (2.4) c | 1 (2.5) | 2 (1.2) |
| Upper gastrointestinal hemorrhage | 0 | 1 (2.4) | 1 (2.4) | 0 | 2 (1.2) |
Abbreviations: D1D8-Q3W—day 1 and 8 of a 3-week cycle; MedDRA—Medical Dictionary for Regulatory Activities Version 19.1; N = number of patients in the safety population; Q2W—every 2 weeks; Q3W—every 3 weeks; QW—weekly; SAE—serious adverse event; TEAE—treatment-emergent adverse event. a Ordered by decreasing frequency in Arm 1. Italicized items are consolidated terms incorporating the multiple MedDRA preferred terms. b One patient died in the 6 mg/kg QW arm because of the SAE gastric hemorrhage, deemed related to ramucirumab. c One patient died in the 6 mg/kg QW arm because of the SAE respiratory failure, deemed related to ramucirumab.