Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer. (NCT NCT00349336)
NCT ID: NCT00349336
Last Updated: 2012-09-18
Results Overview
Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2012-09-18
Participant Flow
A total of 64 patients in 7 centers were enrolled between 01 August 2006 to 28 May 2008. 37 were included in the pharmacokinetic (PK) analyses.
Participant milestones
| Measure |
XELOX+Bevacizumab
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
Baseline characteristics by cohort
| Measure |
XELOX+Bevacizumab
n=32 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=32 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.9 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Weekly Steady-state Exposure of Bevacizumab
|
4090.3 day*ug/mL
Standard Deviation 1047.6
|
4022.4 day*ug/mL
Standard Deviation 1774.2
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Time Zero to Last Measurable Plasma Concentration of Bevacizumab
|
2457.19 day*ug/mL
Standard Deviation 359.5
|
1709.8 day*ug/mL
Standard Deviation 497.0
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Steady-state Exposure of Bevacizumab From Time Zero to Tau
|
2457.0 day*ug/mL
Standard Deviation 360.6
|
1758.4 day*ug/mL
Standard Deviation 468.5
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Maximum Serum Concentration of Bevacizumab at Steady State
|
242 ug/mL
Standard Deviation 31.6
|
215.6 ug/mL
Standard Deviation 53.2
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Minimum Serum Concentration of Bevacizumab at Steady State
|
59.6 ug/ml
Standard Deviation 14.1
|
80.0 ug/ml
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Serum Clearance of Bevacizumab
|
0.236 L/day
Standard Deviation 0.051
|
0.226 L/day
Standard Deviation 0.056
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Time of Maximum Serum Concentration of Bevacizumab
|
6.442 hr
Standard Deviation 6.786
|
4.958 hr
Standard Deviation 3.596
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Volume of Distribution of Bevacizumab at Steady State
|
4.932 L
Standard Deviation 1.409
|
4.908 L
Standard Deviation 1.563
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: 42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.
Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.
Outcome measures
| Measure |
XELOX+Bevacizumab
n=19 Participants
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=18 Participants
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Terminal Half-life of Bevacizumab
|
381.2 hr
Standard Deviation 91.7
|
394.1 hr
Standard Deviation 121.8
|
Adverse Events
XELOX+Bevacizumab
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
FOLFOX-4+Bevacizumab
Serious events: 15 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XELOX+Bevacizumab
n=32 participants at risk
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=32 participants at risk
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
4/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.00%
0/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Ileus
|
3.1%
1/32
|
0.00%
0/32
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Oesophagitis
|
3.1%
1/32
|
0.00%
0/32
|
|
Gastrointestinal disorders
Rectal Haemorhage
|
0.00%
0/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/32
|
3.1%
1/32
|
|
General disorders
Fatigue
|
0.00%
0/32
|
6.2%
2/32
|
|
General disorders
Pyrexia
|
3.1%
1/32
|
3.1%
1/32
|
|
General disorders
Catheter Thrombosis
|
0.00%
0/32
|
3.1%
1/32
|
|
General disorders
Chest Pain
|
3.1%
1/32
|
0.00%
0/32
|
|
Infections and infestations
Anorectal Infection
|
0.00%
0/32
|
3.1%
1/32
|
|
Infections and infestations
Infection
|
0.00%
0/32
|
3.1%
1/32
|
|
Infections and infestations
Sepsis
|
3.1%
1/32
|
0.00%
0/32
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32
|
0.00%
0/32
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
3.1%
1/32
|
0.00%
0/32
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/32
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/32
|
3.1%
1/32
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/32
|
6.2%
2/32
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
3.1%
1/32
|
0.00%
0/32
|
|
Hepatobiliary disorders
Cholecystitis
|
3.1%
1/32
|
0.00%
0/32
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.00%
0/32
|
3.1%
1/32
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/32
|
3.1%
1/32
|
Other adverse events
| Measure |
XELOX+Bevacizumab
n=32 participants at risk
XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
|
FOLFOX-4+Bevacizumab
n=32 participants at risk
FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
62.5%
20/32
|
71.9%
23/32
|
|
Gastrointestinal disorders
Nausea
|
81.2%
26/32
|
50.0%
16/32
|
|
Gastrointestinal disorders
Abdominal Pain
|
34.4%
11/32
|
25.0%
8/32
|
|
Gastrointestinal disorders
Constipation
|
31.2%
10/32
|
28.1%
9/32
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32
|
28.1%
9/32
|
|
Gastrointestinal disorders
Stomatitis
|
15.6%
5/32
|
21.9%
7/32
|
|
Gastrointestinal disorders
Flatulence
|
28.1%
9/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
4/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
3.1%
1/32
|
15.6%
5/32
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.4%
3/32
|
9.4%
3/32
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.4%
3/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
6.2%
2/32
|
9.4%
3/32
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
12.5%
4/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
3.1%
1/32
|
12.5%
4/32
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.2%
2/32
|
3.1%
1/32
|
|
Gastrointestinal disorders
Dry Mouth
|
3.1%
1/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Oral Pain
|
3.1%
1/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Anorectal Discomfort
|
0.00%
0/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Gingival Bleeding
|
6.2%
2/32
|
0.00%
0/32
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/32
|
6.2%
2/32
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/32
|
6.2%
2/32
|
|
General disorders
Fatigue
|
75.0%
24/32
|
71.9%
23/32
|
|
General disorders
Temperature Intolerance
|
46.9%
15/32
|
37.5%
12/32
|
|
General disorders
Mucosal Inflammation
|
18.8%
6/32
|
34.4%
11/32
|
|
General disorders
Pyrexia
|
9.4%
3/32
|
21.9%
7/32
|
|
General disorders
Oedema Peripheral
|
3.1%
1/32
|
18.8%
6/32
|
|
General disorders
Influenza Like Illness
|
6.2%
2/32
|
9.4%
3/32
|
|
General disorders
Injection Site Discolouration
|
9.4%
3/32
|
6.2%
2/32
|
|
General disorders
Pain
|
9.4%
3/32
|
6.2%
2/32
|
|
General disorders
Chest Pain
|
6.2%
2/32
|
6.2%
2/32
|
|
General disorders
Chills
|
3.1%
1/32
|
6.2%
2/32
|
|
General disorders
Mucosal Haemorrhage
|
6.2%
2/32
|
3.1%
1/32
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
46.9%
15/32
|
50.0%
16/32
|
|
Nervous system disorders
Neuropathy Peripheral
|
46.9%
15/32
|
46.9%
15/32
|
|
Nervous system disorders
Headache
|
31.2%
10/32
|
31.2%
10/32
|
|
Nervous system disorders
Dizziness
|
18.8%
6/32
|
18.8%
6/32
|
|
Nervous system disorders
Paraesthesia
|
12.5%
4/32
|
21.9%
7/32
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32
|
12.5%
4/32
|
|
Nervous system disorders
Dysaesthesia
|
3.1%
1/32
|
6.2%
2/32
|
|
Nervous system disorders
Cranial Neuropathy
|
6.2%
2/32
|
0.00%
0/32
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/32
|
6.2%
2/32
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/32
|
6.2%
2/32
|
|
Nervous system disorders
Syncope
|
0.00%
0/32
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
56.2%
18/32
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.9%
7/32
|
28.1%
9/32
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
21.9%
7/32
|
21.9%
7/32
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.4%
3/32
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
12.5%
4/32
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
12.5%
4/32
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
3/32
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
9.4%
3/32
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.4%
3/32
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
6.2%
2/32
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
2/32
|
0.00%
0/32
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.9%
7/32
|
40.6%
13/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
7/32
|
25.0%
8/32
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
9.4%
3/32
|
21.9%
7/32
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
18.8%
6/32
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32
|
18.8%
6/32
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
18.8%
6/32
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.4%
3/32
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.1%
1/32
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Ulcer
|
0.00%
0/32
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/32
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
6.2%
2/32
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
21.9%
7/32
|
15.6%
5/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32
|
21.9%
7/32
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.4%
3/32
|
18.8%
6/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
15.6%
5/32
|
12.5%
4/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.1%
1/32
|
12.5%
4/32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
3.1%
1/32
|
9.4%
3/32
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
6.2%
2/32
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.2%
2/32
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.1%
1/32
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
6.2%
2/32
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/32
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
6.2%
2/32
|
0.00%
0/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
6.2%
2/32
|
0.00%
0/32
|
|
Infections and infestations
Rhinitis
|
15.6%
5/32
|
18.8%
6/32
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.1%
1/32
|
12.5%
4/32
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32
|
6.2%
2/32
|
|
Infections and infestations
Oral Herpes
|
6.2%
2/32
|
6.2%
2/32
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
1/32
|
9.4%
3/32
|
|
Infections and infestations
Central Line Infection
|
0.00%
0/32
|
6.2%
2/32
|
|
Infections and infestations
Eye Infection
|
6.2%
2/32
|
0.00%
0/32
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/32
|
6.2%
2/32
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/32
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
16/32
|
25.0%
8/32
|
|
Metabolism and nutrition disorders
Decrease Appetite
|
6.2%
2/32
|
12.5%
4/32
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/32
|
6.2%
2/32
|
|
Vascular disorders
Hypertension
|
21.9%
7/32
|
21.9%
7/32
|
|
Vascular disorders
Thrombosis
|
3.1%
1/32
|
12.5%
4/32
|
|
Vascular disorders
Flushing
|
0.00%
0/32
|
9.4%
3/32
|
|
Vascular disorders
Hot Flush
|
0.00%
0/32
|
9.4%
3/32
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
4/32
|
43.8%
14/32
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
1/32
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32
|
6.2%
2/32
|
|
Psychiatric disorders
Insomnia
|
28.1%
9/32
|
28.1%
9/32
|
|
Eye disorders
Eye Pain
|
9.4%
3/32
|
6.2%
2/32
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/32
|
15.6%
5/32
|
|
Investigations
Weight Decreased
|
3.1%
1/32
|
15.6%
5/32
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
6.2%
2/32
|
3.1%
1/32
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/32
|
12.5%
4/32
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
1/32
|
9.4%
3/32
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER