Time Frame |
Up to approximately 24 months
|
Adverse Event Reporting Description |
For Adverse Event reporting, the data from Part 1C has been combined with Part 1B participants who received 50 mg INCB001158 + Pembrolizumab combination.
|
|
Arm/Group Title
|
Part 1A - INCB001158 50mg
|
Part 1A - INCB001158 75mg
|
Part 1A and Part 2- INCB001158 100mg
|
Part 1A - INCB001158 150mg
|
Part 1B - INCB001158 50mg + Pembrolizumab
|
Part 1B - INCB001158 75mg + Pembrolizumab
|
Part 1B and Part 3 - INCB001158 100mg + Pembrolizumab
|
Total
|
Arm/Group Description |
INCB001158 administered orally at 5...
|
INCB001158 administered orally at 7...
|
INCB001158 administered orally at 1...
|
INCB001158 administered orally at 1...
|
INCB001158 administered orally at 5...
|
INCB001158 administered orally 75mg...
|
INCB001158 administered orally at 1...
|
Total
|
Arm/Group Description |
INCB001158 administered orally at 50mg twice daily (BID) in participants with advanced/metastatic solid tumors.
|
INCB001158 administered orally at 75mg BID in participants with advanced/metastatic solid tumors.
|
INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
|
INCB001158 administered orally at 150mg BID in participants with advanced/metastatic solid tumors.
|
INCB001158 administered orally at 50mg BID in combination with pembrolizumab at 200 mg IV every 3 weeks (Q3W)
|
INCB001158 administered orally 75mg BID in combination with pembrolizumab at 200 mg IV Q3W
|
INCB001158 administered orally at 100mg BID in combination with pembrolizumab at 200 mg IV Q3W.
|
Total
|
|
|
Part 1A - INCB001158 50mg
|
Part 1A - INCB001158 75mg
|
Part 1A and Part 2- INCB001158 100mg
|
Part 1A - INCB001158 150mg
|
Part 1B - INCB001158 50mg + Pembrolizumab
|
Part 1B - INCB001158 75mg + Pembrolizumab
|
Part 1B and Part 3 - INCB001158 100mg + Pembrolizumab
|
Total
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
0/8 (0.00%)
|
|
0/7 (0.00%)
|
|
12/85 (14.12%)
|
|
0/7 (0.00%)
|
|
3/16 (18.75%)
|
|
3/14 (21.43%)
|
|
24/123 (19.51%)
|
|
42/260 (16.15%)
|
|
|
|
Part 1A - INCB001158 50mg
|
Part 1A - INCB001158 75mg
|
Part 1A and Part 2- INCB001158 100mg
|
Part 1A - INCB001158 150mg
|
Part 1B - INCB001158 50mg + Pembrolizumab
|
Part 1B - INCB001158 75mg + Pembrolizumab
|
Part 1B and Part 3 - INCB001158 100mg + Pembrolizumab
|
Total
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
3/8 (37.50%)
|
|
2/7 (28.57%)
|
|
31/85 (36.47%)
|
|
0/7 (0.00%)
|
|
6/16 (37.50%)
|
|
5/14 (35.71%)
|
|
47/123 (38.21%)
|
|
94/260 (36.15%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
Anaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Cardiac disorders |
|
|
|
|
|
|
|
|
Acute coronary syndrome |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Myocardial infarction |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Pulseless electrical activity |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Supraventricular tachycardia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Endocrine disorders |
|
|
|
|
|
|
|
|
Adrenal haemorrhage |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
Abdominal distension |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Abdominal pain |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
5/85 (5.88%)
|
5 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
7 |
10/260 (3.85%)
|
13 |
Ascites |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
4 |
3/260 (1.15%)
|
4 |
Colitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Constipation |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
2 |
1/260 (0.38%)
|
2 |
Diarrhoea |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
4 |
4/260 (1.54%)
|
5 |
Dysphagia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Gastrointestinal haemorrhage |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Ileus |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
3 |
1/260 (0.38%)
|
3 |
Intestinal obstruction |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Large intestinal haemorrhage |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Large intestinal obstruction |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Nausea |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
5/123 (4.07%)
|
9 |
6/260 (2.31%)
|
10 |
Pancreatitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Rectal haemorrhage |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Small intestinal obstruction |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
3/260 (1.15%)
|
3 |
Vomiting |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
5/123 (4.07%)
|
7 |
6/260 (2.31%)
|
8 |
General disorders |
|
|
|
|
|
|
|
|
Fatigue |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
5/123 (4.07%)
|
6 |
6/260 (2.31%)
|
7 |
Malaise |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Oedema peripheral |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Pyrexia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
3 |
2/260 (0.77%)
|
3 |
Infections and infestations |
|
|
|
|
|
|
|
|
Asymptomatic bacteriuria |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Bacteraemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Bronchitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
2/260 (0.77%)
|
2 |
Cellulitis |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
3/260 (1.15%)
|
3 |
Empyema |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Lung infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Medical device site infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Pneumonia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Pyelonephritis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Sepsis |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
5 |
Septic shock |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Tooth infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Urinary tract infection |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
Head injury |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Post procedural complication |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Postoperative wound infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Investigations |
|
|
|
|
|
|
|
|
Aspartate aminotransferase increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Blood alkaline phosphatase increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Blood bilirubin increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Blood creatinine increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
2 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
3 |
Respirovirus test positive |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Transaminases increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
Decreased appetite |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
4 |
4/260 (1.54%)
|
4 |
Dehydration |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Hypercalcaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
2/260 (0.77%)
|
2 |
Hyperuricaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Hypokalaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Hyponatraemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
3/260 (1.15%)
|
4 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
Back pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
6/260 (2.31%)
|
6 |
Bone pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Flank pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Muscular weakness |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
5/260 (1.92%)
|
5 |
Musculoskeletal pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Osteitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Soft tissue necrosis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
Cancer pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Malignant neoplasm progression |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
5/85 (5.88%)
|
5 |
0/7 (0.00%)
|
0 |
2/16 (12.50%)
|
2 |
3/14 (21.43%)
|
3 |
16/123 (13.01%)
|
16 |
26/260 (10.00%)
|
26 |
Tumour associated fever |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Tumour pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
3 |
2/260 (0.77%)
|
3 |
Nervous system disorders |
|
|
|
|
|
|
|
|
Brain oedema |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Cerebrovascular accident |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Headache |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Hemiparesis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Metabolic encephalopathy |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Myasthenia gravis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Neuralgia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Seizure |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
2/260 (0.77%)
|
2 |
Somnolence |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
Confusional state |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
2 |
2/260 (0.77%)
|
3 |
Delirium |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Hallucination |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Mental status changes |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
Acute kidney injury |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
4 |
Haematuria |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Hydronephrosis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Renal failure |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Tubulointerstitial nephritis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Urinary tract obstruction |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
Vaginal fistula |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
Chronic obstructive pulmonary disease |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Cough |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Dyspnoea |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
3 |
4/260 (1.54%)
|
5 |
Hypoxia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Pneumomediastinum |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Pneumonitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Pulmonary embolism |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Respiratory failure |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
3 |
4/260 (1.54%)
|
5 |
Vascular disorders |
|
|
|
|
|
|
|
|
Deep vein thrombosis |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Flushing |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Hypotension |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
2/260 (0.77%)
|
2 |
Thrombophlebitis superficial |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Thrombosis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
1/260 (0.38%)
|
1 |
Term from vocabulary, MedDRA 19
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Part 1A - INCB001158 50mg
|
Part 1A - INCB001158 75mg
|
Part 1A and Part 2- INCB001158 100mg
|
Part 1A - INCB001158 150mg
|
Part 1B - INCB001158 50mg + Pembrolizumab
|
Part 1B - INCB001158 75mg + Pembrolizumab
|
Part 1B and Part 3 - INCB001158 100mg + Pembrolizumab
|
Total
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
7/8 (87.50%)
|
|
7/7 (100.00%)
|
|
77/85 (90.59%)
|
|
7/7 (100.00%)
|
|
16/16 (100.00%)
|
|
13/14 (92.86%)
|
|
116/123 (94.31%)
|
|
243/260 (93.46%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
Anaemia |
3/8 (37.50%)
|
4 |
3/7 (42.86%)
|
4 |
10/85 (11.76%)
|
11 |
0/7 (0.00%)
|
0 |
2/16 (12.50%)
|
2 |
1/14 (7.14%)
|
1 |
22/123 (17.89%)
|
23 |
41/260 (15.77%)
|
45 |
Cardiac disorders |
|
|
|
|
|
|
|
|
Atrial thrombosis |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Tachycardia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
5 |
5/260 (1.92%)
|
6 |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
Ear discomfort |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Vertigo |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
1 |
4/260 (1.54%)
|
4 |
Endocrine disorders |
|
|
|
|
|
|
|
|
Adrenal insufficiency |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Hyperthyroidism |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Hypothyroidism |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
3/16 (18.75%)
|
3 |
3/14 (21.43%)
|
4 |
13/123 (10.57%)
|
16 |
20/260 (7.69%)
|
24 |
Eye disorders |
|
|
|
|
|
|
|
|
Dry eye |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Eye pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Metamorphopsia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Periorbital oedema |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Visual impairment |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
Abdominal discomfort |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
4/260 (1.54%)
|
4 |
Abdominal distension |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
7/123 (5.69%)
|
7 |
10/260 (3.85%)
|
10 |
Abdominal pain |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
11/85 (12.94%)
|
11 |
1/7 (14.29%)
|
1 |
2/16 (12.50%)
|
3 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
18/260 (6.92%)
|
19 |
Abdominal pain upper |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
6/260 (2.31%)
|
6 |
Constipation |
2/8 (25.00%)
|
2 |
1/7 (14.29%)
|
1 |
18/85 (21.18%)
|
22 |
2/7 (28.57%)
|
2 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
29/123 (23.58%)
|
32 |
53/260 (20.38%)
|
60 |
Diarrhoea |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
5/85 (5.88%)
|
5 |
1/7 (14.29%)
|
1 |
4/16 (25.00%)
|
4 |
2/14 (14.29%)
|
2 |
31/123 (25.20%)
|
44 |
43/260 (16.54%)
|
56 |
Dry mouth |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
6/85 (7.06%)
|
6 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
6/123 (4.88%)
|
6 |
13/260 (5.00%)
|
13 |
Dysphagia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
8/123 (6.50%)
|
8 |
10/260 (3.85%)
|
10 |
Flatulence |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Gastrooesophageal reflux disease |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
3 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
2 |
6/260 (2.31%)
|
7 |
Ileus |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Nausea |
2/8 (25.00%)
|
3 |
3/7 (42.86%)
|
4 |
18/85 (21.18%)
|
21 |
1/7 (14.29%)
|
2 |
3/16 (18.75%)
|
3 |
0/14 (0.00%)
|
0 |
22/123 (17.89%)
|
25 |
49/260 (18.85%)
|
58 |
Odynophagia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Stomatitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
2 |
2/260 (0.77%)
|
3 |
Vomiting |
2/8 (25.00%)
|
2 |
3/7 (42.86%)
|
3 |
9/85 (10.59%)
|
10 |
0/7 (0.00%)
|
0 |
2/16 (12.50%)
|
2 |
0/14 (0.00%)
|
0 |
19/123 (15.45%)
|
24 |
35/260 (13.46%)
|
41 |
General disorders |
|
|
|
|
|
|
|
|
Asthenia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
2/16 (12.50%)
|
2 |
0/14 (0.00%)
|
0 |
11/123 (8.94%)
|
12 |
15/260 (5.77%)
|
16 |
Chest pain |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
2 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
5/260 (1.92%)
|
6 |
Chills |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
2/85 (2.35%)
|
2 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
8/123 (6.50%)
|
8 |
12/260 (4.62%)
|
12 |
Face oedema |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Fatigue |
1/8 (12.50%)
|
1 |
3/7 (42.86%)
|
3 |
22/85 (25.88%)
|
23 |
3/7 (42.86%)
|
3 |
6/16 (37.50%)
|
6 |
3/14 (21.43%)
|
3 |
29/123 (23.58%)
|
31 |
67/260 (25.77%)
|
70 |
Feeling abnormal |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Local swelling |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Malaise |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Mucosal inflammation |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
4 |
Nodule |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Oedema peripheral |
2/8 (25.00%)
|
3 |
0/7 (0.00%)
|
0 |
12/85 (14.12%)
|
12 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
3/14 (21.43%)
|
4 |
8/123 (6.50%)
|
9 |
27/260 (10.38%)
|
30 |
Pain |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
4 |
7/260 (2.69%)
|
7 |
Peripheral swelling |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Procedural pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
4/260 (1.54%)
|
4 |
Pyrexia |
1/8 (12.50%)
|
1 |
1/7 (14.29%)
|
1 |
4/85 (4.71%)
|
5 |
2/7 (28.57%)
|
2 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
14/123 (11.38%)
|
18 |
22/260 (8.46%)
|
27 |
Stoma site pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Temperature intolerance |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
Hepatobiliary disease |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Infections and infestations |
|
|
|
|
|
|
|
|
Conjunctivitis |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Folliculitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Fungal infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
4 |
Nasopharyngitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Oral herpes |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Otitis externa |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Sinusitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
1 |
5/260 (1.92%)
|
5 |
Upper respiratory tract infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
2/14 (14.29%)
|
2 |
8/123 (6.50%)
|
10 |
12/260 (4.62%)
|
14 |
Urinary tract infection |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
4 |
2/7 (28.57%)
|
2 |
2/16 (12.50%)
|
3 |
0/14 (0.00%)
|
0 |
9/123 (7.32%)
|
13 |
16/260 (6.15%)
|
22 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
Contusion |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Fall |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
7/260 (2.69%)
|
7 |
Overdose |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Investigations |
|
|
|
|
|
|
|
|
Activated partial thromboplastin time prolonged |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
7/123 (5.69%)
|
8 |
9/260 (3.46%)
|
10 |
Alanine aminotransferase increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
4/85 (4.71%)
|
4 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
2/14 (14.29%)
|
2 |
21/123 (17.07%)
|
25 |
29/260 (11.15%)
|
33 |
Aspartate aminotransferase increased |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
7/85 (8.24%)
|
9 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
3/14 (21.43%)
|
3 |
23/123 (18.70%)
|
26 |
36/260 (13.85%)
|
41 |
Blood alkaline phosphatase increased |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
5/85 (5.88%)
|
5 |
1/7 (14.29%)
|
1 |
2/16 (12.50%)
|
2 |
0/14 (0.00%)
|
0 |
12/123 (9.76%)
|
12 |
21/260 (8.08%)
|
21 |
Blood bilirubin increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
9/123 (7.32%)
|
10 |
12/260 (4.62%)
|
13 |
Blood creatinine increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
8/85 (9.41%)
|
9 |
2/7 (28.57%)
|
2 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
17/123 (13.82%)
|
21 |
28/260 (10.77%)
|
33 |
Blood iron decreased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Blood lactate dehydrogenase increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
7/123 (5.69%)
|
14 |
7/260 (2.69%)
|
14 |
Blood thyroid stimulating hormone increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
2 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
2 |
International normalised ratio increased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Weight decreased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
12/123 (9.76%)
|
12 |
16/260 (6.15%)
|
16 |
White blood cell count decreased |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
Appetite disorder |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Decreased appetite |
0/8 (0.00%)
|
0 |
2/7 (28.57%)
|
2 |
17/85 (20.00%)
|
17 |
2/7 (28.57%)
|
2 |
3/16 (18.75%)
|
3 |
2/14 (14.29%)
|
2 |
22/123 (17.89%)
|
27 |
48/260 (18.46%)
|
53 |
Dehydration |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
4 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
6/123 (4.88%)
|
6 |
11/260 (4.23%)
|
12 |
Hypercalcaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
2 |
3/260 (1.15%)
|
4 |
Hyperglycaemia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
7/85 (8.24%)
|
12 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
2 |
7/123 (5.69%)
|
9 |
18/260 (6.92%)
|
26 |
Hyperkalaemia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
4 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
6/260 (2.31%)
|
7 |
Hypoalbuminaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
6/85 (7.06%)
|
8 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
2/14 (14.29%)
|
2 |
22/123 (17.89%)
|
33 |
31/260 (11.92%)
|
44 |
Hypocalcaemia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
3 |
5/260 (1.92%)
|
6 |
Hypoglycaemia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Hypokalaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
12/123 (9.76%)
|
15 |
12/260 (4.62%)
|
15 |
Hypomagnesaemia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
12/123 (9.76%)
|
15 |
15/260 (5.77%)
|
18 |
Hyponatraemia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
3 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
3/14 (21.43%)
|
3 |
28/123 (22.76%)
|
35 |
36/260 (13.85%)
|
43 |
Hypophosphataemia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
11/123 (8.94%)
|
17 |
15/260 (5.77%)
|
21 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
Arthralgia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
11/85 (12.94%)
|
12 |
2/7 (28.57%)
|
3 |
0/16 (0.00%)
|
0 |
2/14 (14.29%)
|
2 |
14/123 (11.38%)
|
21 |
30/260 (11.54%)
|
39 |
Back pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
8/85 (9.41%)
|
8 |
3/7 (42.86%)
|
4 |
0/16 (0.00%)
|
0 |
3/14 (21.43%)
|
3 |
15/123 (12.20%)
|
16 |
29/260 (11.15%)
|
31 |
Bone pain |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Flank pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Muscle spasms |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
2/85 (2.35%)
|
3 |
1/7 (14.29%)
|
2 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
3 |
7/260 (2.69%)
|
10 |
Muscular weakness |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
4 |
8/260 (3.08%)
|
8 |
Musculoskeletal pain |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
5/85 (5.88%)
|
5 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
4 |
11/260 (4.23%)
|
11 |
Musculoskeletal stiffness |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Myalgia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
6/85 (7.06%)
|
7 |
2/7 (28.57%)
|
2 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
6/123 (4.88%)
|
6 |
16/260 (6.15%)
|
17 |
Neck pain |
0/8 (0.00%)
|
0 |
2/7 (28.57%)
|
2 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
4 |
Pain in extremity |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
6/85 (7.06%)
|
6 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
3/14 (21.43%)
|
5 |
4/123 (3.25%)
|
4 |
15/260 (5.77%)
|
17 |
Pain in jaw |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
Skin papilloma |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Tumour pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/16 (12.50%)
|
2 |
0/14 (0.00%)
|
0 |
7/123 (5.69%)
|
7 |
9/260 (3.46%)
|
9 |
Tumour ulceration |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Nervous system disorders |
|
|
|
|
|
|
|
|
Ataxia |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Carpal tunnel syndrome |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Dizziness |
1/8 (12.50%)
|
1 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
4 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
13/123 (10.57%)
|
13 |
20/260 (7.69%)
|
21 |
Dysgeusia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
5/123 (4.07%)
|
5 |
9/260 (3.46%)
|
9 |
Headache |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
6/85 (7.06%)
|
6 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
7/123 (5.69%)
|
10 |
15/260 (5.77%)
|
18 |
Hypoaesthesia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/85 (1.18%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
3 |
Neuropathy peripheral |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
4/85 (4.71%)
|
7 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
6/123 (4.88%)
|
6 |
11/260 (4.23%)
|
14 |
Paraesthesia oral |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Peripheral sensory neuropathy |
2/8 (25.00%)
|
2 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
6/260 (2.31%)
|
6 |
Restless legs syndrome |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Somnolence |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Syncope |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Visual acuity reduced |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
Anxiety |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
6/260 (2.31%)
|
6 |
Cognitive disorder |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Confusional state |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
3/85 (3.53%)
|
3 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
2 |
5/260 (1.92%)
|
6 |
Depression |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/85 (1.18%)
|
1 |
2/7 (28.57%)
|
2 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
7/260 (2.69%)
|
7 |
Insomnia |
1/8 (12.50%)
|
1 |
1/7 (14.29%)
|
1 |
6/85 (7.06%)
|
6 |
2/7 (28.57%)
|
2 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
9/123 (7.32%)
|
10 |
19/260 (7.31%)
|
20 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
Acute kidney injury |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
3/260 (1.15%)
|
3 |
Dysuria |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
2/7 (28.57%)
|
2 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
4/260 (1.54%)
|
4 |
Haematuria |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
2/7 (28.57%)
|
2 |
3/16 (18.75%)
|
3 |
0/14 (0.00%)
|
0 |
10/123 (8.13%)
|
14 |
17/260 (6.54%)
|
21 |
Hydronephrosis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
4/260 (1.54%)
|
4 |
Pollakiuria |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
1/7 (14.29%)
|
2 |
0/16 (0.00%)
|
0 |
2/14 (14.29%)
|
2 |
1/123 (0.81%)
|
1 |
6/260 (2.31%)
|
7 |
Proteinuria |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
6/123 (4.88%)
|
12 |
7/260 (2.69%)
|
13 |
Renal vein thrombosis |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
Breast tenderness |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Vaginal haemorrhage |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
2 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
3/260 (1.15%)
|
4 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
Cough |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
7/85 (8.24%)
|
7 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
16/123 (13.01%)
|
19 |
27/260 (10.38%)
|
30 |
Dysphonia |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
5/260 (1.92%)
|
5 |
Dyspnoea |
1/8 (12.50%)
|
1 |
1/7 (14.29%)
|
1 |
12/85 (14.12%)
|
12 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
2/14 (14.29%)
|
2 |
16/123 (13.01%)
|
16 |
33/260 (12.69%)
|
33 |
Dyspnoea exertional |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
1/123 (0.81%)
|
1 |
3/260 (1.15%)
|
3 |
Hypoxia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
2/123 (1.63%)
|
2 |
4/260 (1.54%)
|
4 |
Nasal congestion |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
4/85 (4.71%)
|
4 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
10/123 (8.13%)
|
10 |
14/260 (5.38%)
|
14 |
Oropharyngeal pain |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
2/123 (1.63%)
|
2 |
6/260 (2.31%)
|
6 |
Pneumonitis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
4/260 (1.54%)
|
4 |
Pulmonary embolism |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Rhinorrhoea |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Wheezing |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
3/123 (2.44%)
|
3 |
6/260 (2.31%)
|
7 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
Intertrigo |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Lichenoid keratosis |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Photosensitivity reaction |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Pruritus |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/16 (6.25%)
|
1 |
1/14 (7.14%)
|
1 |
9/123 (7.32%)
|
9 |
12/260 (4.62%)
|
12 |
Rash |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
4/85 (4.71%)
|
5 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
11/123 (8.94%)
|
11 |
16/260 (6.15%)
|
17 |
Rash macular |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
1/123 (0.81%)
|
1 |
2/260 (0.77%)
|
2 |
Rash maculo-papular |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
6/123 (4.88%)
|
6 |
7/260 (2.69%)
|
7 |
Vascular disorders |
|
|
|
|
|
|
|
|
Haematochezia |
0/8 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
1/14 (7.14%)
|
1 |
0/123 (0.00%)
|
0 |
1/260 (0.38%)
|
1 |
Haemorrhoids |
0/8 (0.00%)
|
0 |
1/7 (14.29%)
|
1 |
1/85 (1.18%)
|
1 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
0/123 (0.00%)
|
0 |
2/260 (0.77%)
|
2 |
Hot flush |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
3/85 (3.53%)
|
3 |
1/7 (14.29%)
|
1 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
3/123 (2.44%)
|
3 |
8/260 (3.08%)
|
8 |
Hypertension |
1/8 (12.50%)
|
1 |
0/7 (0.00%)
|
0 |
2/85 (2.35%)
|
2 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
4/123 (3.25%)
|
4 |
7/260 (2.69%)
|
7 |
Hypotension |
0/8 (0.00%)
|
0 |
2/7 (28.57%)
|
3 |
0/85 (0.00%)
|
0 |
0/7 (0.00%)
|
0 |
0/16 (0.00%)
|
0 |
0/14 (0.00%)
|
0 |
6/123 (4.88%)
|
6 |
8/260 (3.08%)
|
9 |
Term from vocabulary, MedDRA 19
Indicates events were collected by systematic assessment
|