Trial Outcomes & Findings for Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas (NCT NCT03504423)
NCT ID: NCT03504423
Last Updated: 2023-01-03
Results Overview
Defined as the duration from the date of randomization to the date of death from any cause
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
528 participants
Primary outcome timeframe
38 months
Results posted on
2023-01-03
Participant Flow
Participant milestones
| Measure |
CPI-613, mFolfirinox
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Overall Study
STARTED
|
266
|
262
|
|
Overall Study
COMPLETED
|
259
|
235
|
|
Overall Study
NOT COMPLETED
|
7
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
CPI-613, mFolfirinox
n=266 Participants
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=262 Participants
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
Total
n=528 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
61.62 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
61.47 years
STANDARD_DEVIATION 8.30 • n=7 Participants
|
61.55 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
201 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 38 monthsDefined as the duration from the date of randomization to the date of death from any cause
Outcome measures
| Measure |
CPI-613, mFolfirinox
n=266 Participants
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=262 Participants
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Overall Survival (OS)
|
11.10 months
Interval 10.22 to 12.94
|
11.73 months
Interval 10.12 to 13.24
|
SECONDARY outcome
Timeframe: 38 monthsDefined as the duration from the date of randomization to the date of progressive disease or death from any cause. Progressive Disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
CPI-613, mFolfirinox
n=266 Participants
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=262 Participants
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Progression Free Survival (PFS)
|
7.82 months
Interval 6.97 to 10.91
|
7.98 months
Interval 7.23 to 11.14
|
SECONDARY outcome
Timeframe: 38 monthsDefined as the rate of Complete Response (CR) plus Partial Response (PR): Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of diameters of target lesions;
Outcome measures
| Measure |
CPI-613, mFolfirinox
n=266 Participants
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=262 Participants
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Overall Response Rate (ORR)
|
104 Participants
|
90 Participants
|
Adverse Events
CPI-613, mFolfirinox
Serious events: 140 serious events
Other events: 258 other events
Deaths: 140 deaths
Folfirinox
Serious events: 133 serious events
Other events: 232 other events
Deaths: 133 deaths
Serious adverse events
| Measure |
CPI-613, mFolfirinox
n=259 participants at risk
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=235 participants at risk
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
10/259 • 38 months
|
8.9%
21/235 • 38 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
3/259 • 38 months
|
7.2%
17/235 • 38 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.39%
1/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Cardiac disorders
Acute left ventricular failure
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrial flutter
|
0.39%
1/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Tachycardia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
15/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Colitis
|
1.9%
5/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Gastrointestinal disorders
Constipation
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
9/259 • 38 months
|
7.7%
18/235 • 38 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Enteritis
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Nausea
|
2.7%
7/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.77%
2/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Gastrointestinal disorders
Subileus
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
7/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
General disorders
Asthenia
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
General disorders
Device related thrombosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Drug intolerance
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Fatigue
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
General physical health deterioration
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
General disorders
Hyperthermia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Incarcerated hernia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Non-cardiac chest pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Pyrexia
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
General disorders
Sudden death
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
1/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
5/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Arthritis bacterial
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Arthritis infective
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Bacteraemia
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Biliary tract infection
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Cholecystitis infective
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Corona virus infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Device related infection
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Endocarditis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Infected skin ulcer
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Influenza
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Liver abscess
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Pneumonia
|
1.2%
3/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Sepsis
|
3.9%
10/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Infections and infestations
Septic shock
|
2.3%
6/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Urinary tract infection
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Investigations
Blood creatinine increased
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Neutrophil count decreased
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Investigations
Platelet count decreased
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Investigations
Transaminases increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Weight decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
White blood cell count decreased
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.39%
1/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Encephalopathy
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Loss of consciousness
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Neuralgia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Syncope
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Product Issues
Device occlusion
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Product Issues
Stent malfunction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Confusional state
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Delirium
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Depression
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Mental status changes
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Embolism
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Hypertension
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Hypertensive crisis
|
3.9%
10/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Hypotension
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
Other adverse events
| Measure |
CPI-613, mFolfirinox
n=259 participants at risk
CPI-613, mFolfirinox
CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.
mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.
mFolfirinox: given immediately after CPI-613 administration
|
Folfirinox
n=235 participants at risk
Folfirinox
Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Folfirinox: Folfirinox
|
|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Anaemia
|
46.3%
120/259 • 38 months
|
40.0%
94/235 • 38 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
7/259 • 38 months
|
8.1%
19/235 • 38 months
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.1%
8/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.5%
48/259 • 38 months
|
20.9%
49/235 • 38 months
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.1%
34/259 • 38 months
|
16.2%
38/235 • 38 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
6/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Cardiac disorders
Atrial flutter
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Bradycardia
|
2.3%
6/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Cardiac disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Intracardiac mass
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Palpitations
|
2.3%
6/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Cardiac disorders
Sinus bradycardia
|
1.9%
5/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.6%
12/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Tachycardia
|
3.1%
8/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Cardiac disorders
Congenital, familial and genetic disorders
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Cardiac disorders
Hereditary non-polyposis colorectal cancer syndrome
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Dacryostenosis acquired
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Ear and labyrinth disorders
Dry eye
|
1.2%
3/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Ear and labyrinth disorders
Dyschromatopsia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Eye pain
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Eye swelling
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Glaucoma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Lacrimation increased
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Ocular hyperaemia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Periorbital oedema
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Photophobia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Retinal detachment
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Swelling of eyelid
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Vision blurred
|
4.2%
11/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Ear and labyrinth disorders
Visual acuity reduced
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Ear and labyrinth disorders
Visual impairment
|
1.9%
5/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Ear and labyrinth disorders
Vitreous floaters
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Ear and labyrinth disorders
Xerophthalmia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
7/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal distension
|
9.7%
25/259 • 38 months
|
7.2%
17/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain
|
34.7%
90/259 • 38 months
|
35.7%
84/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
22/259 • 38 months
|
4.7%
11/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.39%
1/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Anal fissure
|
0.39%
1/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Anal incontinence
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Ascites
|
5.8%
15/259 • 38 months
|
4.7%
11/235 • 38 months
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Colitis
|
3.1%
8/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Gastrointestinal disorders
Constipation
|
36.7%
95/259 • 38 months
|
28.5%
67/235 • 38 months
|
|
Gastrointestinal disorders
Diarrhoea
|
67.2%
174/259 • 38 months
|
74.0%
174/235 • 38 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
19/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Gastrointestinal disorders
Dumping syndrome
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
30/259 • 38 months
|
10.6%
25/235 • 38 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
11/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Gastrointestinal disorders
Enteritis
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Eructation
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Faeces pale
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
21/259 • 38 months
|
6.0%
14/235 • 38 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastric varices
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
5/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.3%
24/259 • 38 months
|
8.9%
21/235 • 38 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Gingival pain
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Gingival recession
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Glossitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Glossodynia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Haematochezia
|
3.9%
10/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.2%
11/259 • 38 months
|
5.5%
13/235 • 38 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Ileus
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Lip dry
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Lip oedema
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Lip swelling
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Lip ulceration
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Melaena
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Nausea
|
74.5%
193/259 • 38 months
|
66.0%
155/235 • 38 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Oesophagitis
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Oral pain
|
3.5%
9/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Proctalgia
|
2.3%
6/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.2%
3/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.77%
2/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Gastrointestinal disorders
Stomatitis
|
20.1%
52/259 • 38 months
|
20.0%
47/235 • 38 months
|
|
Gastrointestinal disorders
Subileus
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Swollen tongue
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Tongue dry
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Gastrointestinal disorders
Toothache
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.9%
5/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Gastrointestinal disorders
Vomiting
|
41.3%
107/259 • 38 months
|
40.9%
96/235 • 38 months
|
|
General disorders
Administration site extravasation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Asthenia
|
13.1%
34/259 • 38 months
|
19.6%
46/235 • 38 months
|
|
General disorders
Catheter site discolouration
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Catheter site erythema
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Catheter site inflammation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Catheter site oedema
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Catheter site pain
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Chest discomfort
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Chest pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Chills
|
6.2%
16/259 • 38 months
|
5.5%
13/235 • 38 months
|
|
General disorders
Complication associated with device
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Device embolisation
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Device related thrombosis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Discomfort
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Drug intolerance
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Early satiety
|
1.2%
3/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
General disorders
Facial pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Fatigue
|
59.1%
153/259 • 38 months
|
53.6%
126/235 • 38 months
|
|
General disorders
Feeling cold
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Feeling hot
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Gait disturbance
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
General physical health deterioration
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
General disorders
Generalised oedema
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Hernia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Hyperthermia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Incarcerated hernia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Influenza like illness
|
0.39%
1/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
General disorders
Injection site reaction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Localised oedema
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
General disorders
Malaise
|
1.2%
3/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
General disorders
Mucosal inflammation
|
10.0%
26/259 • 38 months
|
9.4%
22/235 • 38 months
|
|
General disorders
Non-cardiac chest pain
|
5.8%
15/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
General disorders
Oedema
|
1.2%
3/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
General disorders
Oedema peripheral
|
17.0%
44/259 • 38 months
|
15.3%
36/235 • 38 months
|
|
General disorders
Pain
|
2.3%
6/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
General disorders
Performance status decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Peripheral swelling
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
General disorders
Pyrexia
|
15.4%
40/259 • 38 months
|
17.4%
41/235 • 38 months
|
|
General disorders
Sensation of foreign body
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Sudden death
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Swelling
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Systemic inflammatory response syndrome
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Temperature intolerance
|
12.0%
31/259 • 38 months
|
8.9%
21/235 • 38 months
|
|
General disorders
Unevaluable event
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
General disorders
Xerosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
2.3%
6/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.77%
2/259 • 38 months
|
4.7%
11/235 • 38 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Cholestasis
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Hepatic pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.77%
2/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.7%
7/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Ocular icterus
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Hepatobiliary disorders
Immune system disorders
|
1.9%
5/259 • 38 months
|
3.8%
9/235 • 38 months
|
|
Hepatobiliary disorders
Anaphylactic reaction
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Hepatobiliary disorders
Drug hypersensitivity
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Hepatobiliary disorders
Hypersensitivity
|
1.2%
3/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Hepatobiliary disorders
Seasonal allergy
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Abscess
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Arthritis bacterial
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Arthritis infective
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Bacteraemia
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
Bacterial colitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Bacterial infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Biliary tract infection
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Bronchiolitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Bronchitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Candida infection
|
2.7%
7/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Catheter site infection
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Cellulitis
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Cholecystitis infective
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Clostridium difficile infection
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Conjunctivitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Corona virus infection
|
2.3%
6/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Device related infection
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Ear infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Endocarditis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Enterovirus infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Folliculitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Fungal infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Fungal oesophagitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Fungal skin infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Gastroenteritis
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
Gingival abscess
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Gingivitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Herpes simplex
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Herpes virus infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Herpes zoster
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Infected cyst
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Infected skin ulcer
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Influenza
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Liver abscess
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Lung infection
|
0.39%
1/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Infections and infestations
Mucosal infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Myelitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Nail infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Nasopharyngitis
|
0.39%
1/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Oral candidiasis
|
1.9%
5/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Infections and infestations
Oral fungal infection
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Infections and infestations
Oral herpes
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Paronychia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Pharyngitis
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Pneumonia
|
3.1%
8/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Rash pustular
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Rhinitis
|
2.7%
7/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Rhinovirus infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Sepsis
|
4.2%
11/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Infections and infestations
Septic shock
|
2.3%
6/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Sinusitis
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Skin infection
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Tooth abscess
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Tooth infection
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
8/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Infections and infestations
Urinary tract infection
|
3.5%
9/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Infections and infestations
Wound infection
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.6%
12/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
16/259 • 38 months
|
9.4%
22/235 • 38 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Transfusion related complication
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.3%
24/259 • 38 months
|
6.4%
15/235 • 38 months
|
|
Investigations
Alanine aminotransferase increased
|
23.2%
60/259 • 38 months
|
17.4%
41/235 • 38 months
|
|
Investigations
Amylase increased
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Anion gap decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.0%
57/259 • 38 months
|
14.0%
33/235 • 38 months
|
|
Investigations
Bacterial test positive
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Band neutrophil percentage increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Blood albumin decreased
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Blood alkaline phosphatase increased
|
27.4%
71/259 • 38 months
|
18.7%
44/235 • 38 months
|
|
Investigations
Blood bilirubin decreased
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Blood bilirubin increased
|
5.8%
15/259 • 38 months
|
7.2%
17/235 • 38 months
|
|
Investigations
blood calcium decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
blood chloride decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
blood chloride increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
blood cholesterol increased
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
blood creatinine decreased
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
blood creatinine increased
|
3.9%
10/259 • 38 months
|
6.4%
15/235 • 38 months
|
|
Investigations
blood fibrinogen decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
blood glucose increased
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Investigations
blood iron decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
blood lactic acid increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
blood magnesium decreased
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
blood phosphorus decreased
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
blood phosphorus increased
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
blood potassium decreased
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
bloo pressure increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Blood sodium decreased
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
Blood urea decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Blood urea increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Cardiac murmur
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Coronavirus test positive
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Ejection fraction decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Electrocardiogram QT prolonged
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
Grip strength decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Haematocrit decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Heart rate increased
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Hepatic enzyme increased
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
Immature granulocyte count increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
International normalised ratio increased
|
9.3%
24/259 • 38 months
|
10.6%
25/235 • 38 months
|
|
Investigations
Lipase increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Lymphocyte count decreased
|
14.3%
37/259 • 38 months
|
9.8%
23/235 • 38 months
|
|
Investigations
Lymphocyte count increased
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Mean cell volume increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Metamyelocyte count increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Monocyte count decreased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Monocyte count increased
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Neutrophil count decreased
|
28.2%
73/259 • 38 months
|
26.0%
61/235 • 38 months
|
|
Investigations
Neutrophil count increased
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Investigations
Pancreatic enzymes decreased
|
1.5%
4/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Investigations
Platelet count decreased
|
30.9%
80/259 • 38 months
|
28.5%
67/235 • 38 months
|
|
Investigations
Platelet count increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Prostatic specific antigen increased
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Investigations
Protein total decreased
|
0.77%
2/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Investigations
Prothrombin time prolonged
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Red blood cell count increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Transaminases increased
|
0.77%
2/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Investigations
Troponin increased
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Urine output decreased
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Investigations
Weight decreased
|
33.6%
87/259 • 38 months
|
33.2%
78/235 • 38 months
|
|
Investigations
Weight increased
|
4.2%
11/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Investigations
White blood cell count decreased
|
15.4%
40/259 • 38 months
|
14.5%
34/235 • 38 months
|
|
Investigations
White blood cell count increased
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Cell death
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
111/259 • 38 months
|
43.4%
102/235 • 38 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.7%
38/259 • 38 months
|
15.3%
36/235 • 38 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Gout
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.7%
33/259 • 38 months
|
10.2%
24/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
11/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.3%
6/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
1.9%
5/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
20.8%
54/259 • 38 months
|
17.9%
42/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.4%
32/259 • 38 months
|
10.2%
24/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.2%
11/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
37.1%
96/259 • 38 months
|
37.0%
87/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.8%
46/259 • 38 months
|
20.9%
49/235 • 38 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.1%
52/259 • 38 months
|
16.6%
39/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.8%
41/259 • 38 months
|
12.8%
30/235 • 38 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Pseudohyponatraemia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
18/259 • 38 months
|
6.0%
14/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.6%
43/259 • 38 months
|
15.3%
36/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
5/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.5%
9/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
11/259 • 38 months
|
4.7%
11/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
16/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
8/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
16/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
6/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
11/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.39%
1/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Ageusia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Amnesia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Aphasia
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Ataxia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Cholinergic syndrome
|
4.6%
12/259 • 38 months
|
4.7%
11/235 • 38 months
|
|
Nervous system disorders
Cognitive disorder
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Disturbance in attention
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Dizziness
|
19.3%
50/259 • 38 months
|
13.6%
32/235 • 38 months
|
|
Nervous system disorders
Dizziness postural
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Dysaesthesia
|
1.9%
5/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Nervous system disorders
Dysarthria
|
2.3%
6/259 • 38 months
|
3.8%
9/235 • 38 months
|
|
Nervous system disorders
Dysgeusia
|
20.1%
52/259 • 38 months
|
17.9%
42/235 • 38 months
|
|
Nervous system disorders
Encephalopathy
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Headache
|
9.3%
24/259 • 38 months
|
11.1%
26/235 • 38 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Hypoaesthesia
|
2.3%
6/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Nervous system disorders
Intellectual disability
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Loss of consciousness
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Memory impairment
|
1.5%
4/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Migraine
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Muscle spasticity
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Neuralgia
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Neuropathy peripheral
|
40.5%
105/259 • 38 months
|
34.0%
80/235 • 38 months
|
|
Nervous system disorders
Neurotoxicity
|
0.77%
2/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Nervous system disorders
Paraesthesia
|
13.1%
34/259 • 38 months
|
14.5%
34/235 • 38 months
|
|
Nervous system disorders
Parosmia
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.2%
55/259 • 38 months
|
25.5%
60/235 • 38 months
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Polyneuropathy
|
1.9%
5/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Nervous system disorders
Presyncope
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Sciatica
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Sinus headache
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Somnolence
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Nervous system disorders
Speech disorder
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Syncope
|
3.9%
10/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Nervous system disorders
Thermohyperaesthesia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Nervous system disorders
Tremor
|
2.3%
6/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Nervous system disorders
Visual field defect
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Nervous system disorders
Vocal cord paresis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Product Issues
Device dislocation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Product Issues
Device malfunction
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Product Issues
Device occlusion
|
1.2%
3/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Product Issues
Stent malfunction
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Psychiatric disorders
Adjustment disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Agitation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
26/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Confusional state
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Psychiatric disorders
Delirium
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Depression
|
6.6%
17/259 • 38 months
|
3.8%
9/235 • 38 months
|
|
Psychiatric disorders
Disorientation
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Drug dependence
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Dysphoria
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Hallucination, visual
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Insomnia
|
13.9%
36/259 • 38 months
|
12.8%
30/235 • 38 months
|
|
Psychiatric disorders
Irritability
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Mental status changes
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Psychiatric disorders
Paranoia
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Psychiatric disorders
Restlessness
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Psychiatric disorders
Sleep disorder
|
0.39%
1/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Psychiatric disorders
Stress
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
4/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Renal and urinary disorders
Bladder discomfort
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Renal and urinary disorders
Chromaturia
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Renal and urinary disorders
Dysuria
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Renal and urinary disorders
Haematuria
|
1.2%
3/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Renal and urinary disorders
Micturition urgency
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Nocturia
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Pollakiuria
|
1.5%
4/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Renal and urinary disorders
Prerenal failure
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
4/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Renal and urinary disorders
Renal failure
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Renal pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Urinary hesitation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
4/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
5/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Ovarian vein thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Penile pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
31/259 • 38 months
|
10.6%
25/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.2%
29/259 • 38 months
|
13.2%
31/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
22/259 • 38 months
|
8.5%
20/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.3%
24/259 • 38 months
|
10.2%
24/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
3/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
4/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
11/259 • 38 months
|
3.8%
9/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.77%
2/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.5%
22/259 • 38 months
|
4.3%
10/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.7%
7/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.9%
18/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.2%
3/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.8%
54/259 • 38 months
|
17.4%
41/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
3/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.77%
2/259 • 38 months
|
2.1%
5/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
17/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.3%
6/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.9%
10/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.2%
3/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.7%
7/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia
|
5.8%
15/259 • 38 months
|
3.0%
7/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
16/259 • 38 months
|
5.1%
12/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
20/259 • 38 months
|
3.4%
8/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.9%
5/259 • 38 months
|
1.7%
4/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.2%
3/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.39%
1/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.3%
6/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.77%
2/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Vascular disorders
Angiopathy
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
16/259 • 38 months
|
2.6%
6/235 • 38 months
|
|
Vascular disorders
Embolism
|
4.6%
12/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Flushing
|
2.7%
7/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Haematoma
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Hot flush
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Hypertension
|
17.4%
45/259 • 38 months
|
7.7%
18/235 • 38 months
|
|
Vascular disorders
Hypertensive crisis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Hypotension
|
9.3%
24/259 • 38 months
|
10.6%
25/235 • 38 months
|
|
Vascular disorders
Jugular vein thrombosis
|
0.39%
1/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
3/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Vascular disorders
Pallor
|
0.77%
2/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/259 • 38 months
|
0.43%
1/235 • 38 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Phlebitis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Thrombophlebitis
|
1.5%
4/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/259 • 38 months
|
0.85%
2/235 • 38 months
|
|
Vascular disorders
Thrombosis
|
1.2%
3/259 • 38 months
|
1.3%
3/235 • 38 months
|
|
Vascular disorders
Varicose vein
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.39%
1/259 • 38 months
|
0.00%
0/235 • 38 months
|
|
Vascular disorders
Venous thrombosis
|
0.77%
2/259 • 38 months
|
0.43%
1/235 • 38 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place