Time Frame |
From first administration of treatment till 30 days after last dose of treatment.
|
Adverse Event Reporting Description |
At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for>1 year".
|
|
Arm/Group Title
|
Regorafenib (Double Blind Only)
|
Placebo (Double Blind Only)
|
Placebo, Open Label Only (Switch to Regorafenib)
|
Treated With Regorafenib at Any Time
|
Treated With Regorafenib for > 1 Year
|
Arm/Group Description |
Participants received Regorafenib (...
|
Participants received matching Plac...
|
Participants switched to Open-label...
|
Treated with Regorafenib at any tim...
|
Treated with Regorafenib for > 1 ye...
|
Arm/Group Description |
Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
|
Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
|
Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks
|
Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
|
Treated with Regorafenib for > 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
|
|
|
Regorafenib (Double Blind Only)
|
Placebo (Double Blind Only)
|
Placebo, Open Label Only (Switch to Regorafenib)
|
Treated With Regorafenib at Any Time
|
Treated With Regorafenib for > 1 Year
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
40/41 (97.56%)
|
|
7/8 (87.50%)
|
|
47/58 (81.03%)
|
|
155/190 (81.58%)
|
|
48/75 (64.00%)
|
|
|
|
Regorafenib (Double Blind Only)
|
Placebo (Double Blind Only)
|
Placebo, Open Label Only (Switch to Regorafenib)
|
Treated With Regorafenib at Any Time
|
Treated With Regorafenib for > 1 Year
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
23/41 (56.10%)
|
|
8/8 (100.00%)
|
|
31/58 (53.45%)
|
|
103/190 (54.21%)
|
|
39/75 (52.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Anemia |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
2/190 (1.05%)
|
3 |
0/75 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
Acute coronary syndrome |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
7/190 (3.68%)
|
7 |
6/75 (8.00%)
|
6 |
Atrial fibrillation |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Cardiac arrest |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Chest pain - cardiac |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
2 |
1/75 (1.33%)
|
2 |
Conduction disorder |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Heart failure |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Cardiac disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
|
|
|
Congenital, familial and genetic disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
|
Vertigo |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
Eye disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Gastrointestinal disorders |
|
|
|
|
|
Abdominal pain |
5/41 (12.20%)
|
5 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
9/190 (4.74%)
|
10 |
1/75 (1.33%)
|
1 |
Anal fistula |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Ascites |
3/41 (7.32%)
|
4 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
4 |
0/75 (0.00%)
|
0 |
Colonic fistula |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Colonic obstruction |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
1/190 (0.53%)
|
2 |
0/75 (0.00%)
|
0 |
Colonic perforation |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
2/190 (1.05%)
|
4 |
1/75 (1.33%)
|
2 |
Constipation |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
2/75 (2.67%)
|
2 |
Diarrhea |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
4 |
2/75 (2.67%)
|
3 |
Gastric hemorrhage |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Intra-abdominal hemorrhage |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
3 |
0/75 (0.00%)
|
0 |
Ileus |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Lower gastrointestinal hemorrhage |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Nausea |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Obstruction gastric |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Gastrointestinal disorders - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Peritoneal necrosis |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Retroperitoneal hemorrhage |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Small intestinal obstruction |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
2 |
1/75 (1.33%)
|
2 |
Upper gastrointestinal hemorrhage |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Vomiting |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
General disorders |
|
|
|
|
|
Death NOS |
1/41 (2.44%)
|
1 |
2/8 (25.00%)
|
2 |
1/58 (1.72%)
|
1 |
3/190 (1.58%)
|
3 |
2/75 (2.67%)
|
2 |
Edema limbs |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
1/190 (0.53%)
|
2 |
0/75 (0.00%)
|
0 |
Fatigue |
2/41 (4.88%)
|
4 |
1/8 (12.50%)
|
2 |
2/58 (3.45%)
|
2 |
5/190 (2.63%)
|
7 |
2/75 (2.67%)
|
2 |
Fever |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
5/190 (2.63%)
|
5 |
2/75 (2.67%)
|
2 |
Malaise |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Multi-organ failure |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Non-cardiac chest pain |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
0/190 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
General disorders and administration site conditions - Other |
1/41 (2.44%)
|
1 |
1/8 (12.50%)
|
1 |
2/58 (3.45%)
|
3 |
5/190 (2.63%)
|
6 |
3/75 (4.00%)
|
3 |
Pain |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
3 |
3/190 (1.58%)
|
4 |
1/75 (1.33%)
|
1 |
Hepatobiliary disorders |
|
|
|
|
|
Bile duct stenosis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Cholecystitis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
2/75 (2.67%)
|
2 |
Hepatic failure |
1/41 (2.44%)
|
2 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
3/190 (1.58%)
|
4 |
0/75 (0.00%)
|
0 |
Hepatic hemorrhage |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
3 |
1/75 (1.33%)
|
1 |
Hepatobiliary disorders - Other |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Portal vein thrombosis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
Abdominal infection |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Appendicitis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Bronchial infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
3 |
1/75 (1.33%)
|
2 |
Catheter related infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
1/190 (0.53%)
|
2 |
0/75 (0.00%)
|
0 |
Enterocolitis infectious |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
3 |
2/190 (1.05%)
|
3 |
1/75 (1.33%)
|
2 |
Lung infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Infections and infestations - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
4 |
8/190 (4.21%)
|
9 |
3/75 (4.00%)
|
4 |
Sepsis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
3/190 (1.58%)
|
3 |
1/75 (1.33%)
|
1 |
Upper respiratory infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
3 |
3/75 (4.00%)
|
3 |
Urinary tract infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Wound infection |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
Fracture |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
4/190 (2.11%)
|
5 |
3/75 (4.00%)
|
4 |
Hip fracture |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Investigations |
|
|
|
|
|
Alanine aminotransferase increased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
3/190 (1.58%)
|
6 |
1/75 (1.33%)
|
3 |
Aspartate aminotransferase increased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Blood bilirubin increased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
3/190 (1.58%)
|
3 |
1/75 (1.33%)
|
1 |
Creatinine increased |
1/41 (2.44%)
|
2 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
2 |
0/75 (0.00%)
|
0 |
INR increased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Neutrophil count decreased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Investigations - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Platelet count decreased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
1/190 (0.53%)
|
2 |
0/75 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
Acidosis |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Anorexia |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Dehydration |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
3 |
3/75 (4.00%)
|
3 |
Hyperglycemia |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
0/190 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
Hyperkalemia |
1/41 (2.44%)
|
3 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
3 |
0/75 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
Back pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Generalized muscle weakness |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Musculoskeletal and connective tissue disorder - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Muscle weakness right-sided |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
6/190 (3.16%)
|
6 |
3/75 (4.00%)
|
3 |
Tumor pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
4 |
3/190 (1.58%)
|
5 |
1/75 (1.33%)
|
1 |
Nervous system disorders |
|
|
|
|
|
Amnesia |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Hypoglossal nerve disorder |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Intracranial hemorrhage |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Nervous system disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Paresthesia |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Reversible posterior leukoencephalopathy syndrome |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Somnolence |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Stroke |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
2/75 (2.67%)
|
2 |
Transient ischemic attacks |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
2/75 (2.67%)
|
2 |
Psychiatric disorders |
|
|
|
|
|
Confusion |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Mania |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
4 |
0/58 (0.00%)
|
0 |
0/190 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
Psychiatric disorders - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
Acute kidney injury |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
4/190 (2.11%)
|
5 |
1/75 (1.33%)
|
1 |
Renal and urinary disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
3/190 (1.58%)
|
4 |
1/75 (1.33%)
|
2 |
Renal colic |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Urinary retention |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
Adult respiratory distress syndrome |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Dyspnea |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Pleural effusion |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Pneumonitis |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Respiratory failure |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
Rash maculo-papular |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Surgical and medical procedures |
|
|
|
|
|
Surgical and medical procedures - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
4/190 (2.11%)
|
4 |
2/75 (2.67%)
|
2 |
Vascular disorders |
|
|
|
|
|
Hypertension |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Vascular disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
0/75 (0.00%)
|
0 |
Peripheral ischemia |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
1/190 (0.53%)
|
1 |
1/75 (1.33%)
|
1 |
Thromboembolic event |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
2 |
4/190 (2.11%)
|
5 |
0/75 (0.00%)
|
0 |
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by non-systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Regorafenib (Double Blind Only)
|
Placebo (Double Blind Only)
|
Placebo, Open Label Only (Switch to Regorafenib)
|
Treated With Regorafenib at Any Time
|
Treated With Regorafenib for > 1 Year
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
40/41 (97.56%)
|
|
7/8 (87.50%)
|
|
58/58 (100.00%)
|
|
189/190 (99.47%)
|
|
75/75 (100.00%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Anemia |
4/41 (9.76%)
|
7 |
0/8 (0.00%)
|
0 |
11/58 (18.97%)
|
25 |
35/190 (18.42%)
|
77 |
17/75 (22.67%)
|
35 |
Blood and lymphatic system disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
9 |
6/190 (3.16%)
|
17 |
4/75 (5.33%)
|
9 |
Ear and labyrinth disorders |
|
|
|
|
|
Hearing impaired |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
7/190 (3.68%)
|
7 |
5/75 (6.67%)
|
5 |
Ear and labyrinth disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
4 |
7/190 (3.68%)
|
7 |
4/75 (5.33%)
|
4 |
Endocrine disorders |
|
|
|
|
|
Hypothyroidism |
4/41 (9.76%)
|
4 |
0/8 (0.00%)
|
0 |
6/58 (10.34%)
|
6 |
39/190 (20.53%)
|
50 |
25/75 (33.33%)
|
32 |
Eye disorders |
|
|
|
|
|
Blurred vision |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
7/190 (3.68%)
|
7 |
7/75 (9.33%)
|
7 |
Eye disorders - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
6/190 (3.16%)
|
6 |
4/75 (5.33%)
|
4 |
Gastrointestinal disorders |
|
|
|
|
|
Abdominal pain |
14/41 (34.15%)
|
18 |
0/8 (0.00%)
|
0 |
16/58 (27.59%)
|
23 |
62/190 (32.63%)
|
122 |
26/75 (34.67%)
|
60 |
Ascites |
2/41 (4.88%)
|
2 |
1/8 (12.50%)
|
1 |
2/58 (3.45%)
|
2 |
6/190 (3.16%)
|
8 |
1/75 (1.33%)
|
3 |
Bloating |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
7/190 (3.68%)
|
10 |
6/75 (8.00%)
|
9 |
Constipation |
10/41 (24.39%)
|
14 |
5/8 (62.50%)
|
6 |
16/58 (27.59%)
|
30 |
63/190 (33.16%)
|
101 |
28/75 (37.33%)
|
52 |
Diarrhea |
15/41 (36.59%)
|
20 |
1/8 (12.50%)
|
1 |
24/58 (41.38%)
|
67 |
96/190 (50.53%)
|
353 |
53/75 (70.67%)
|
281 |
Dyspepsia |
4/41 (9.76%)
|
4 |
1/8 (12.50%)
|
2 |
6/58 (10.34%)
|
9 |
19/190 (10.00%)
|
39 |
11/75 (14.67%)
|
30 |
Dry mouth |
5/41 (12.20%)
|
5 |
0/8 (0.00%)
|
0 |
5/58 (8.62%)
|
6 |
15/190 (7.89%)
|
16 |
5/75 (6.67%)
|
6 |
Flatulence |
4/41 (9.76%)
|
4 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
10/190 (5.26%)
|
11 |
5/75 (6.67%)
|
6 |
Mucositis oral |
14/41 (34.15%)
|
18 |
2/8 (25.00%)
|
3 |
21/58 (36.21%)
|
48 |
81/190 (42.63%)
|
174 |
38/75 (50.67%)
|
111 |
Nausea |
9/41 (21.95%)
|
12 |
3/8 (37.50%)
|
4 |
18/58 (31.03%)
|
33 |
61/190 (32.11%)
|
110 |
32/75 (42.67%)
|
66 |
Gastrointestinal disorders - Other |
4/41 (9.76%)
|
4 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
7 |
17/190 (8.95%)
|
21 |
11/75 (14.67%)
|
15 |
Stomach pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
7/190 (3.68%)
|
7 |
5/75 (6.67%)
|
5 |
Vomiting |
10/41 (24.39%)
|
11 |
3/8 (37.50%)
|
5 |
12/58 (20.69%)
|
24 |
48/190 (25.26%)
|
85 |
21/75 (28.00%)
|
54 |
General disorders |
|
|
|
|
|
Chills |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
4 |
11/190 (5.79%)
|
19 |
8/75 (10.67%)
|
16 |
Edema limbs |
3/41 (7.32%)
|
4 |
3/8 (37.50%)
|
3 |
11/58 (18.97%)
|
20 |
33/190 (17.37%)
|
72 |
17/75 (22.67%)
|
53 |
Fatigue |
18/41 (43.90%)
|
32 |
3/8 (37.50%)
|
4 |
32/58 (55.17%)
|
83 |
104/190 (54.74%)
|
251 |
46/75 (61.33%)
|
137 |
Fever |
10/41 (24.39%)
|
17 |
1/8 (12.50%)
|
1 |
18/58 (31.03%)
|
24 |
52/190 (27.37%)
|
83 |
25/75 (33.33%)
|
46 |
Flu like symptoms |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
18/190 (9.47%)
|
22 |
14/75 (18.67%)
|
17 |
Localized edema |
2/41 (4.88%)
|
2 |
1/8 (12.50%)
|
1 |
3/58 (5.17%)
|
5 |
8/190 (4.21%)
|
10 |
5/75 (6.67%)
|
7 |
Non-cardiac chest pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
7/190 (3.68%)
|
8 |
6/75 (8.00%)
|
7 |
General disorders and administration site conditions - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
5 |
10/190 (5.26%)
|
11 |
5/75 (6.67%)
|
6 |
Pain |
5/41 (12.20%)
|
8 |
1/8 (12.50%)
|
1 |
19/58 (32.76%)
|
46 |
55/190 (28.95%)
|
115 |
29/75 (38.67%)
|
73 |
Immune system disorders |
|
|
|
|
|
Allergic reaction |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
4/190 (2.11%)
|
4 |
4/75 (5.33%)
|
4 |
Infections and infestations |
|
|
|
|
|
Bronchial infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
4 |
11/190 (5.79%)
|
12 |
9/75 (12.00%)
|
10 |
Infections and infestations - Other |
2/41 (4.88%)
|
3 |
0/8 (0.00%)
|
0 |
5/58 (8.62%)
|
7 |
21/190 (11.05%)
|
39 |
13/75 (17.33%)
|
26 |
Rash pustular |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
17 |
13/190 (6.84%)
|
49 |
10/75 (13.33%)
|
42 |
Sinusitis |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
6/190 (3.16%)
|
6 |
5/75 (6.67%)
|
5 |
Skin infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
4 |
6/190 (3.16%)
|
7 |
4/75 (5.33%)
|
4 |
Tooth infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
6/190 (3.16%)
|
6 |
5/75 (6.67%)
|
5 |
Upper respiratory infection |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
9/58 (15.52%)
|
12 |
26/190 (13.68%)
|
41 |
21/75 (28.00%)
|
36 |
Urinary tract infection |
2/41 (4.88%)
|
3 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
4 |
12/190 (6.32%)
|
17 |
6/75 (8.00%)
|
9 |
Investigations |
|
|
|
|
|
Alanine aminotransferase increased |
4/41 (9.76%)
|
9 |
1/8 (12.50%)
|
2 |
6/58 (10.34%)
|
15 |
20/190 (10.53%)
|
41 |
4/75 (5.33%)
|
10 |
Alkaline phosphatase increased |
1/41 (2.44%)
|
1 |
1/8 (12.50%)
|
1 |
3/58 (5.17%)
|
6 |
11/190 (5.79%)
|
21 |
3/75 (4.00%)
|
4 |
Aspartate aminotransferase increased |
4/41 (9.76%)
|
9 |
2/8 (25.00%)
|
2 |
8/58 (13.79%)
|
15 |
23/190 (12.11%)
|
58 |
6/75 (8.00%)
|
24 |
Blood bilirubin increased |
4/41 (9.76%)
|
6 |
1/8 (12.50%)
|
3 |
9/58 (15.52%)
|
15 |
22/190 (11.58%)
|
52 |
7/75 (9.33%)
|
27 |
GGT increased |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
2 |
2/58 (3.45%)
|
2 |
4/190 (2.11%)
|
4 |
1/75 (1.33%)
|
1 |
Lipase increased |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
11 |
6/190 (3.16%)
|
19 |
3/75 (4.00%)
|
14 |
Neutrophil count decreased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
6/58 (10.34%)
|
8 |
13/190 (6.84%)
|
25 |
6/75 (8.00%)
|
12 |
Investigations - Other |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
14 |
14/190 (7.37%)
|
49 |
10/75 (13.33%)
|
28 |
Platelet count decreased |
1/41 (2.44%)
|
5 |
0/8 (0.00%)
|
0 |
6/58 (10.34%)
|
25 |
15/190 (7.89%)
|
46 |
10/75 (13.33%)
|
34 |
White blood cell decreased |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
6/190 (3.16%)
|
17 |
4/75 (5.33%)
|
15 |
Weight gain |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
2/58 (3.45%)
|
3 |
3/190 (1.58%)
|
4 |
2/75 (2.67%)
|
3 |
Weight loss |
4/41 (9.76%)
|
5 |
2/8 (25.00%)
|
2 |
11/58 (18.97%)
|
20 |
40/190 (21.05%)
|
72 |
22/75 (29.33%)
|
44 |
Metabolism and nutrition disorders |
|
|
|
|
|
Anorexia |
15/41 (36.59%)
|
21 |
3/8 (37.50%)
|
5 |
20/58 (34.48%)
|
42 |
77/190 (40.53%)
|
134 |
32/75 (42.67%)
|
72 |
Dehydration |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
5/58 (8.62%)
|
5 |
6/190 (3.16%)
|
8 |
4/75 (5.33%)
|
6 |
Hypoalbuminemia |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
9/190 (4.74%)
|
10 |
2/75 (2.67%)
|
2 |
Hypocalcemia |
1/41 (2.44%)
|
2 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
8 |
9/190 (4.74%)
|
15 |
4/75 (5.33%)
|
4 |
Hypokalemia |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
12/58 (20.69%)
|
18 |
20/190 (10.53%)
|
31 |
13/75 (17.33%)
|
22 |
Hyponatremia |
0/41 (0.00%)
|
0 |
2/8 (25.00%)
|
2 |
3/58 (5.17%)
|
4 |
8/190 (4.21%)
|
11 |
2/75 (2.67%)
|
2 |
Hypophosphatemia |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
10/190 (5.26%)
|
13 |
5/75 (6.67%)
|
7 |
Hypercalcemia |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
3/58 (5.17%)
|
3 |
4/190 (2.11%)
|
4 |
4/75 (5.33%)
|
4 |
Hyperglycemia |
1/41 (2.44%)
|
3 |
0/8 (0.00%)
|
0 |
5/58 (8.62%)
|
5 |
13/190 (6.84%)
|
18 |
9/75 (12.00%)
|
10 |
Hyperuricemia |
1/41 (2.44%)
|
1 |
1/8 (12.50%)
|
1 |
2/58 (3.45%)
|
2 |
7/190 (3.68%)
|
7 |
2/75 (2.67%)
|
2 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
Arthralgia |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
7 |
14/190 (7.37%)
|
20 |
8/75 (10.67%)
|
14 |
Back pain |
2/41 (4.88%)
|
2 |
1/8 (12.50%)
|
1 |
4/58 (6.90%)
|
6 |
21/190 (11.05%)
|
29 |
14/75 (18.67%)
|
20 |
Bone pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
3 |
5/190 (2.63%)
|
9 |
5/75 (6.67%)
|
9 |
Flank pain |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
5/190 (2.63%)
|
5 |
4/75 (5.33%)
|
4 |
Generalized muscle weakness |
1/41 (2.44%)
|
1 |
1/8 (12.50%)
|
1 |
4/58 (6.90%)
|
7 |
6/190 (3.16%)
|
14 |
3/75 (4.00%)
|
11 |
Myalgia |
5/41 (12.20%)
|
5 |
3/8 (37.50%)
|
3 |
10/58 (17.24%)
|
17 |
34/190 (17.89%)
|
76 |
17/75 (22.67%)
|
49 |
Neck pain |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
2/190 (1.05%)
|
2 |
1/75 (1.33%)
|
1 |
Musculoskeletal and connective tissue disorder - Other |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
5 |
14/190 (7.37%)
|
17 |
10/75 (13.33%)
|
12 |
Pain in extremity |
5/41 (12.20%)
|
5 |
1/8 (12.50%)
|
2 |
7/58 (12.07%)
|
15 |
28/190 (14.74%)
|
51 |
17/75 (22.67%)
|
37 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Tumor pain |
1/41 (2.44%)
|
2 |
1/8 (12.50%)
|
1 |
3/58 (5.17%)
|
4 |
7/190 (3.68%)
|
9 |
2/75 (2.67%)
|
2 |
Nervous system disorders |
|
|
|
|
|
Dizziness |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
1/58 (1.72%)
|
1 |
6/190 (3.16%)
|
16 |
6/75 (8.00%)
|
16 |
Dysgeusia |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
4 |
17/190 (8.95%)
|
19 |
9/75 (12.00%)
|
11 |
Headache |
4/41 (9.76%)
|
4 |
0/8 (0.00%)
|
0 |
11/58 (18.97%)
|
21 |
37/190 (19.47%)
|
72 |
23/75 (30.67%)
|
55 |
Paresthesia |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
5 |
11/190 (5.79%)
|
19 |
9/75 (12.00%)
|
13 |
Peripheral sensory neuropathy |
5/41 (12.20%)
|
7 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
8 |
16/190 (8.42%)
|
22 |
6/75 (8.00%)
|
7 |
Somnolence |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
0/190 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
Anxiety |
4/41 (9.76%)
|
4 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
4 |
9/190 (4.74%)
|
10 |
4/75 (5.33%)
|
5 |
Confusion |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
1/58 (1.72%)
|
1 |
2/190 (1.05%)
|
2 |
0/75 (0.00%)
|
0 |
Depression |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
10/190 (5.26%)
|
11 |
4/75 (5.33%)
|
5 |
Insomnia |
3/41 (7.32%)
|
3 |
1/8 (12.50%)
|
1 |
3/58 (5.17%)
|
4 |
21/190 (11.05%)
|
22 |
14/75 (18.67%)
|
15 |
Renal and urinary disorders |
|
|
|
|
|
Hematuria |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
7/190 (3.68%)
|
9 |
3/75 (4.00%)
|
3 |
Renal and urinary disorders - Other |
3/41 (7.32%)
|
3 |
0/8 (0.00%)
|
0 |
0/58 (0.00%)
|
0 |
10/190 (5.26%)
|
12 |
4/75 (5.33%)
|
5 |
Proteinuria |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
6/58 (10.34%)
|
11 |
23/190 (12.11%)
|
58 |
9/75 (12.00%)
|
21 |
Urinary frequency |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
2 |
7/190 (3.68%)
|
8 |
4/75 (5.33%)
|
5 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
Cough |
1/41 (2.44%)
|
1 |
1/8 (12.50%)
|
1 |
11/58 (18.97%)
|
18 |
27/190 (14.21%)
|
44 |
15/75 (20.00%)
|
32 |
Dyspnea |
4/41 (9.76%)
|
6 |
0/8 (0.00%)
|
0 |
7/58 (12.07%)
|
9 |
22/190 (11.58%)
|
32 |
11/75 (14.67%)
|
16 |
Epistaxis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
6 |
10/190 (5.26%)
|
15 |
7/75 (9.33%)
|
10 |
Hiccups |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
1 |
0/58 (0.00%)
|
0 |
0/190 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
Hoarseness |
8/41 (19.51%)
|
8 |
0/8 (0.00%)
|
0 |
9/58 (15.52%)
|
11 |
42/190 (22.11%)
|
71 |
17/75 (22.67%)
|
36 |
Pneumonitis |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
5/190 (2.63%)
|
5 |
4/75 (5.33%)
|
4 |
Voice alteration |
2/41 (4.88%)
|
2 |
1/8 (12.50%)
|
1 |
11/58 (18.97%)
|
12 |
28/190 (14.74%)
|
32 |
14/75 (18.67%)
|
17 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
Alopecia |
7/41 (17.07%)
|
9 |
0/8 (0.00%)
|
0 |
21/58 (36.21%)
|
26 |
62/190 (32.63%)
|
84 |
33/75 (44.00%)
|
49 |
Dry skin |
2/41 (4.88%)
|
3 |
0/8 (0.00%)
|
0 |
2/58 (3.45%)
|
3 |
13/190 (6.84%)
|
15 |
7/75 (9.33%)
|
8 |
Erythema multiforme |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
3 |
10/190 (5.26%)
|
17 |
7/75 (9.33%)
|
12 |
Erythroderma |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
4/58 (6.90%)
|
5 |
9/190 (4.74%)
|
11 |
6/75 (8.00%)
|
6 |
Hyperhidrosis |
0/41 (0.00%)
|
0 |
1/8 (12.50%)
|
2 |
2/58 (3.45%)
|
2 |
6/190 (3.16%)
|
11 |
4/75 (5.33%)
|
9 |
Skin and subcutaneous tissue disorders - Other |
3/41 (7.32%)
|
3 |
0/8 (0.00%)
|
0 |
7/58 (12.07%)
|
10 |
27/190 (14.21%)
|
41 |
17/75 (22.67%)
|
28 |
Pain of skin |
0/41 (0.00%)
|
0 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
9/190 (4.74%)
|
39 |
6/75 (8.00%)
|
36 |
Palmar-plantar erythrodysesthesia syndrome |
17/41 (41.46%)
|
37 |
1/8 (12.50%)
|
1 |
39/58 (67.24%)
|
151 |
126/190 (66.32%)
|
666 |
58/75 (77.33%)
|
455 |
Pruritus |
4/41 (9.76%)
|
4 |
1/8 (12.50%)
|
2 |
7/58 (12.07%)
|
8 |
20/190 (10.53%)
|
27 |
10/75 (13.33%)
|
15 |
Rash acneiform |
2/41 (4.88%)
|
2 |
0/8 (0.00%)
|
0 |
3/58 (5.17%)
|
3 |
12/190 (6.32%)
|
12 |
7/75 (9.33%)
|
7 |
Rash maculo-papular |
6/41 (14.63%)
|
7 |
0/8 (0.00%)
|
0 |
8/58 (13.79%)
|
10 |
32/190 (16.84%)
|
71 |
16/75 (21.33%)
|
26 |
Vascular disorders |
|
|
|
|
|
Hypotension |
1/41 (2.44%)
|
1 |
0/8 (0.00%)
|
0 |
1/58 (1.72%)
|
1 |
7/190 (3.68%)
|
8 |
4/75 (5.33%)
|
5 |
Hypertension |
18/41 (43.90%)
|
32 |
3/8 (37.50%)
|
3 |
37/58 (63.79%)
|
97 |
124/190 (65.26%)
|
697 |
62/75 (82.67%)
|
552 |
Thromboembolic event |
0/41 (0.00%)
|
0 |
2/8 (25.00%)
|
2 |
1/58 (1.72%)
|
1 |
6/190 (3.16%)
|
7 |
5/75 (6.67%)
|
5 |
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by non-systematic assessment
|