Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer. (NCT NCT01227707)
NCT ID: NCT01227707
Last Updated: 2015-08-17
Results Overview
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
6 to 8 weeks following completion of neoadjuvant treatment
Results posted on
2015-08-17
Participant Flow
Participant milestones
| Measure |
Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil
Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m\^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil
Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m\^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
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|---|---|
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Overall Study
Adverse Event
|
10
|
|
Overall Study
Progression of disease
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient non-compliance
|
3
|
|
Overall Study
Medical decision
|
6
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Baseline characteristics by cohort
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Age, Continuous
|
61.49 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 8 weeks following completion of neoadjuvant treatmentPopulation: ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=40 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
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|---|---|
|
Percentage of Participants With Pathological Complete Response (pCR)
|
10.00 percentage of participants
Interval 2.79 to 23.66
|
SECONDARY outcome
Timeframe: Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)Population: ITT population
The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T0, N0
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T0, N0
|
4.65 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T1, N0
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T1, N0
|
4.65 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T1, NX
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T1, NX
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T2, N0
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T2, N0
|
18.60 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T2, N1
|
9.30 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T2, N1
|
9.30 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T2, NX
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T2, NX
|
6.98 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T3, N0
|
32.56 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T3, N0
|
18.60 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T3, N1
|
46.51 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T3, N1
|
9.30 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T3, N2
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T3, N2
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T3, NX
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T3, NX
|
6.98 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T4, N0
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T4, N0
|
4.65 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T4, N1
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T4, N1
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T4, N2
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T4, N2
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: T4, N3
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: T4, N3
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: TX, N0
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: TX, N0
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: TX, N2
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: TX, N2
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: M0
|
97.67 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: M0
|
81.40 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: M1
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: M1
|
2.33 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline: MX
|
0 percentage of participants
|
|
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
End of NAT: MX
|
9.30 percentage of participants
|
SECONDARY outcome
Timeframe: 6 to 8 weeks after completion of study treatmentPopulation: ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=40 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
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|---|---|
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Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Anterior resection
|
70.0 percentage of participants
|
|
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Abdomen-peritoneal amputation (Miles)
|
22.5 percentage of participants
|
|
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Other
|
3.0 percentage of participants
|
|
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Colostomy, temporary (n=32)
|
47.50 percentage of participants
|
|
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Colostomy, definitive (n=32)
|
32.50 percentage of participants
|
|
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
No colostomy
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: BL and within 6 weeks after the completion of study treatmentPopulation: ITT population
Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
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|---|---|
|
Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
CR of target lesion(s)
|
11.63 percentage of participants
|
|
Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
CR of non-target lesion(s)
|
18.60 percentage of participants
|
SECONDARY outcome
Timeframe: BL and within 6 weeks after the completion of study treatmentPopulation: ITT population
Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
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|---|---|
|
Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
|
9.30 percentage of participants
|
SECONDARY outcome
Timeframe: BL and within 6 weeks after the completion of study treatmentPopulation: ITT population
The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
|
4.65 percentage of participants
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 monthsPopulation: ITT population; only participants who underwent radical surgery were included in the analysis
The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=38 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Percentage of Participants With Relapse During Follow-Up
No Relapse
|
84.21 percentage of participants
|
|
Percentage of Participants With Relapse During Follow-Up
1 Relapse
|
7.89 percentage of participants
|
|
Percentage of Participants With Relapse During Follow-Up
2 Relapses
|
7.89 percentage of participants
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 monthsPopulation: ITT population
DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Disease-Free Survival (DFS) - Percentage of Participants With an Event
|
30.23 percentage of participants
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 monthsPopulation: ITT population
The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
DFS - Time to Event
|
27.43 months
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 monthsPopulation: ITT population
OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
|
25.58 percentage of participants
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 monthsPopulation: ITT population
OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
OS - Time to Event
|
32.14 months
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 monthsPopulation: ITT population
TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Time to Disease Progression (TTP) - Percentage of Participants With an Event
|
27.91 percentage of participants
|
SECONDARY outcome
Timeframe: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 monthsPopulation: ITT population
TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=43 Participants
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
TTP - Time to Event
|
27.68 months
Standard Deviation 1.72
|
Adverse Events
Bv+Capecitabine/Bv+Leucovorin+5-FU
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=42 participants at risk
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Cardiac disorders
Miocardic ischemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Bowel perforation
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Cardiac disorders
Cardiac ischemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Injury, poisoning and procedural complications
Anastomosis dehiscence
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Intestinal occlusion
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Injury, poisoning and procedural complications
Postoperative abscess
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Metabolism and nutrition disorders
Ipokaliemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
Other adverse events
| Measure |
Bv+Capecitabine/Bv+Leucovorin+5-FU
n=42 participants at risk
Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m\^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m\^2 IV (over 2 hours) followed by 5-FU 400 mg/m\^2 IV bolus and then 5-FU 600 mg/m\^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.9%
5/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
7/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
6/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
6/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
4/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
18/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Hematochezia
|
19.0%
8/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
21.4%
9/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
23.8%
10/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Proctitis
|
11.9%
5/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
3/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
16.7%
7/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
General disorders
Asthenia
|
14.3%
6/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
General disorders
Fatigue
|
9.5%
4/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
General disorders
Pyrexia
|
7.1%
3/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Infections and infestations
Cystitis
|
9.5%
4/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
3/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Vascular disorders
Hypertension
|
14.3%
6/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Cardiac disorders
Tachycardia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Eye disorders
Conjunctivitis
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Anal fistula
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Mucous stools
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Perianal erythema
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
General disorders
Chest pain
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
General disorders
Mucosal inflammation
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Infections and infestations
Iatrogenic infection
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Infections and infestations
Influenza
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Infections and infestations
Oral herpes
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Investigations
Transaminases abnormal
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Nervous system disorders
Headache
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Nervous system disorders
Neurotoxicity
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Nervous system disorders
Paraesthesia
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Renal and urinary disorders
Strangury
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Vascular disorders
Arterial thrombosis
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
|
Additional Information
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 the 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