Trial Outcomes & Findings for PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery (NCT NCT01515787)
NCT ID: NCT01515787
Last Updated: 2024-02-02
Results Overview
Number of Participants with Pelvic R0 Resection
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
1194 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
Group 1
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. \>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Overall Study
STARTED
|
597
|
597
|
|
Overall Study
COMPLETED
|
585
|
543
|
|
Overall Study
NOT COMPLETED
|
12
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing Patient Data
Baseline characteristics by cohort
| Measure |
Group 1
n=585 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. \>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. \>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. \>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. \>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.\>
\> surgery: low anterior resection with total mesorectal excision
|
Total
n=1128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=585 Participants
|
57 years
n=543 Participants
|
57 years
n=1128 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=585 Participants
|
173 Participants
n=543 Participants
|
389 Participants
n=1128 Participants
|
|
Sex: Female, Male
Male
|
369 Participants
n=585 Participants
|
370 Participants
n=543 Participants
|
739 Participants
n=1128 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=585 Participants
|
48 Participants
n=543 Participants
|
96 Participants
n=1128 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
516 Participants
n=585 Participants
|
475 Participants
n=543 Participants
|
991 Participants
n=1128 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=585 Participants
|
20 Participants
n=543 Participants
|
41 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=585 Participants
|
0 Participants
n=543 Participants
|
0 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=585 Participants
|
19 Participants
n=543 Participants
|
50 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=585 Participants
|
0 Participants
n=543 Participants
|
0 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=585 Participants
|
17 Participants
n=543 Participants
|
49 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
White
|
492 Participants
n=585 Participants
|
467 Participants
n=543 Participants
|
959 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=585 Participants
|
40 Participants
n=543 Participants
|
70 Participants
n=1128 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=585 Participants
|
0 Participants
n=543 Participants
|
0 Participants
n=1128 Participants
|
|
Country of residence
Canada
|
51 Participants
n=585 Participants
|
45 Participants
n=543 Participants
|
96 Participants
n=1128 Participants
|
|
Country of residence
Switzerland
|
10 Participants
n=585 Participants
|
9 Participants
n=543 Participants
|
19 Participants
n=1128 Participants
|
|
Country of residence
United States
|
524 Participants
n=585 Participants
|
489 Participants
n=543 Participants
|
1013 Participants
n=1128 Participants
|
|
Body-mass index
|
28.4 kg/m^2
n=585 Participants
|
28.1 kg/m^2
n=543 Participants
|
28.3 kg/m^2
n=1128 Participants
|
|
History of diabetes
Yes
|
81 Participants
n=585 Participants
|
83 Participants
n=543 Participants
|
164 Participants
n=1128 Participants
|
|
History of diabetes
No
|
504 Participants
n=585 Participants
|
460 Participants
n=543 Participants
|
964 Participants
n=1128 Participants
|
|
History of cardiovascular disease
Yes
|
106 Participants
n=585 Participants
|
98 Participants
n=543 Participants
|
204 Participants
n=1128 Participants
|
|
History of cardiovascular disease
No
|
479 Participants
n=585 Participants
|
445 Participants
n=543 Participants
|
924 Participants
n=1128 Participants
|
|
Highest education level
Less than high school
|
29 Participants
n=568 Participants • Missing Patient Data
|
29 Participants
n=531 Participants • Missing Patient Data
|
58 Participants
n=1099 Participants • Missing Patient Data
|
|
Highest education level
High school diploma or GED certificate
|
214 Participants
n=585 Participants • Missing Patient Data
|
201 Participants
n=543 Participants • Missing Patient Data
|
415 Participants
n=1128 Participants • Missing Patient Data
|
|
Highest education level
Some college
|
119 Participants
n=585 Participants • Missing Patient Data
|
102 Participants
n=543 Participants • Missing Patient Data
|
221 Participants
n=1128 Participants • Missing Patient Data
|
|
Highest education level
College degree or higher
|
206 Participants
n=585 Participants • Missing Patient Data
|
199 Participants
n=543 Participants • Missing Patient Data
|
405 Participants
n=1128 Participants • Missing Patient Data
|
|
ECOG performance-status score
0 or 1
|
582 Participants
n=585 Participants
|
540 Participants
n=543 Participants
|
1122 Participants
n=1128 Participants
|
|
ECOG performance-status score
2
|
3 Participants
n=585 Participants
|
3 Participants
n=543 Participants
|
6 Participants
n=1128 Participants
|
|
Primary rectal tumor on digital examination
Rectal tumor not palpable
|
290 Participants
n=580 Participants • Missing Patient Data
|
259 Participants
n=536 Participants • Missing Patient Data
|
549 Participants
n=1116 Participants • Missing Patient Data
|
|
Primary rectal tumor on digital examination
Rectal tumor palpable
|
290 Participants
n=585 Participants • Missing Patient Data
|
277 Participants
n=543 Participants • Missing Patient Data
|
567 Participants
n=1128 Participants • Missing Patient Data
|
|
Rectal tumor location
|
8 cm
n=585 Participants
|
8 cm
n=543 Participants
|
8 cm
n=1128 Participants
|
|
Rectal tumor location
≤5 cm from anal verge
|
83 Participants
n=585 Participants
|
89 Participants
n=543 Participants
|
172 Participants
n=1128 Participants
|
|
Rectal tumor location
>5 to ≤10 cm from anal verge
|
375 Participants
n=585 Participants
|
344 Participants
n=543 Participants
|
719 Participants
n=1128 Participants
|
|
Rectal tumor location
>10 cm from anal verge
|
127 Participants
n=585 Participants
|
109 Participants
n=543 Participants
|
236 Participants
n=1128 Participants
|
|
Clinical stage
T2 node positive
|
63 Participants
n=584 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
38 Participants
n=543 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
101 Participants
n=1127 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
|
Clinical stage
T3 node negative
|
232 Participants
n=585 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
198 Participants
n=543 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
430 Participants
n=1128 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
|
Clinical stage
T3 node positive
|
289 Participants
n=585 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
307 Participants
n=543 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
596 Participants
n=1128 Participants • T1 is if the maximum pre-biopsy diameter was ≤ 2 cm and had at most one of the following high-risk features: poorly differentiated histology, location on the mucosal (non-hair bearing) lip or ear, presence of perineural invasion, or depth of invasion to Clark's level ≥ IV or \> 2 mm.T2 is if \> 2 cm in maximum pre-biopsy diameter or had ≥ 2 of the 7th edition AJCC high-risk features. T3 is if invaded the one or more of the facial bones (including the maxilla, mandible, orbit, or temporal bones.
|
|
Staging performed with MRI
Yes
|
494 Participants
n=585 Participants
|
458 Participants
n=543 Participants
|
952 Participants
n=1128 Participants
|
|
Staging performed with MRI
No
|
91 Participants
n=585 Participants
|
85 Participants
n=543 Participants
|
176 Participants
n=1128 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsNumber of Participants with Pelvic R0 Resection
Outcome measures
| Measure |
Group 1
n=535 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=510 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Pelvic R0 Resection Rate
|
529 Participants
|
495 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsDisease-free Survival (DFS): The distribution of DFS by group will be estimated using the method of Kaplan-Meier. 5 year disease free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Log-rank test will be used to compare DFS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis.
Outcome measures
| Measure |
Group 1
n=585 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
DFS
|
114 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsPathologic Complete Response (pCR): The pCR rate is defined as number of patients who achieve pCR divided by total number of patients included in the analysis population (see definition in Section 16.3.3.1) in each group. Patients who didn't undergo surgery will be classified as non-pCR. Point estimate and confidence interval (according to approach of Duffy and Santner) will be calculated by treatment groups. Chi-square test will be used to compare the pCR rates between groups.
Outcome measures
| Measure |
Group 1
n=535 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=510 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Pathologic Complete Response
|
117 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsOverall Survival (OS): OS is defined as time from randomization to the date of death due to all causes. The distribution of OS by group will be estimated using the method of Kaplan-Meier. Five year survival rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Logrank test will be used to compare OS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis.
Outcome measures
| Measure |
Group 1
n=585 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Overall Survival
|
74 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsRates of Receiving 5FUCMT: For selective group patients, the proportion of patients who received 1) pre-operative 5FUCMT, 2) post-operative 5FUCMT, 3) either pre or post-operative 5FUCMT, and confidence intervals (according to approach of Duffy and Santner) will be reported.
Outcome measures
| Measure |
Group 1
n=585 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Rates of Receiving Pre- or Post-operative 5FUCMT
|
61 Participants
|
543 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsTime to Local Recurrence (TLR): The distribution of TLR by group will be estimated using the method of Kaplan-Meier. 5 year local recurrence free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. The comparison of the cumulative incidence of local recurrence between groups, treating distant recurrence and death as competing risks using the test of Gray (Annals of Statistics, 1988) will be conducted.
Outcome measures
| Measure |
Group 1
n=585 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Local Recurrence (TLR):
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsneoadjuvant rectal (NAR) score =\[5 \* pN - 3(cT - pT) + 12\]\^2/9.61. cT is an element of the set {1, 2, 3, 4}, pT is in {0, 1, 2, 3, 4}, and pN is in {0, 1, 2}. cT clinical tumor stage, pT pathologic tumor stage, pN pathologic nodal stage. Low (NAR \<8), intermediate (NAR = 8-16), and high (NAR \>16). Low is better and high is worse.
Outcome measures
| Measure |
Group 1
n=535 Participants
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
\>
\> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group.
* FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=510 Participants
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
\>
\> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
\>
\> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
\>
\> surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Neoadjuvant Rectal Score
Low (< 8)
|
157 Participants
|
161 Participants
|
|
Neoadjuvant Rectal Score
Intermediate (8-16)
|
247 Participants
|
230 Participants
|
|
Neoadjuvant Rectal Score
High (> 16)
|
130 Participants
|
114 Participants
|
Adverse Events
Group 1
Serious events: 10 serious events
Other events: 582 other events
Deaths: 74 deaths
Group 2
Serious events: 7 serious events
Other events: 534 other events
Deaths: 67 deaths
Serious adverse events
| Measure |
Group 1
n=585 participants at risk
5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 participants at risk
surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Heart failure
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal perforation
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
General disorders
Death NOS
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
General disorders
Sudden death NOS
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Stroke
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
Other adverse events
| Measure |
Group 1
n=585 participants at risk
5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
|
Group 2
n=543 participants at risk
surgery: low anterior resection with total mesorectal excision
|
|---|---|---|
|
Infections and infestations
Device related infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Endocarditis infective
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Gum infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.7%
10/585 • Number of events 11 • Up to 5 years
|
3.7%
20/543 • Number of events 21 • Up to 5 years
|
|
Infections and infestations
Kidney infection
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Lip infection
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Lung infection
|
0.51%
3/585 • Number of events 5 • Up to 5 years
|
0.74%
4/543 • Number of events 5 • Up to 5 years
|
|
Infections and infestations
Meningitis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Mucosal infection
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.17%
1/585 • Number of events 3 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Paronychia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Pelvic infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
12.6%
74/585 • Number of events 168 • Up to 5 years
|
12.0%
65/543 • Number of events 106 • Up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.85%
5/585 • Number of events 9 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
12/585 • Number of events 13 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Asystole
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
1.1%
6/543 • Number of events 7 • Up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
Heart failure
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Palpitations
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
1.3%
7/543 • Number of events 10 • Up to 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.34%
2/585 • Number of events 13 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.37%
2/543 • Number of events 5 • Up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/585 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 4 • Up to 5 years
|
|
Eye disorders
Blurred vision
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Eye disorders
Dry eye
|
0.51%
3/585 • Number of events 8 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.68%
4/585 • Number of events 8 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Eye pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Eye disorders
Optic nerve disorder
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Retinal detachment
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Eye disorders
Retinopathy
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Eye disorders
Vitreous hemorrhage
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Eye disorders
Watering eyes
|
0.51%
3/585 • Number of events 5 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
15/585 • Number of events 22 • Up to 5 years
|
3.5%
19/543 • Number of events 22 • Up to 5 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.51%
3/585 • Number of events 7 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Anal mucositis
|
0.34%
2/585 • Number of events 4 • Up to 5 years
|
0.92%
5/543 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Anal pain
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Anal ulcer
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
1.3%
7/543 • Number of events 9 • Up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.92%
5/543 • Number of events 5 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.2%
7/585 • Number of events 8 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
64.6%
378/585 • Number of events 1459 • Up to 5 years
|
45.9%
249/543 • Number of events 567 • Up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.17%
1/585 • Number of events 4 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
68.5%
401/585 • Number of events 1537 • Up to 5 years
|
81.4%
442/543 • Number of events 1490 • Up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
1.1%
6/543 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
10/585 • Number of events 19 • Up to 5 years
|
1.1%
6/543 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
22.6%
132/585 • Number of events 318 • Up to 5 years
|
6.4%
35/543 • Number of events 47 • Up to 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.2%
7/585 • Number of events 12 • Up to 5 years
|
2.8%
15/543 • Number of events 22 • Up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
7/585 • Number of events 27 • Up to 5 years
|
2.0%
11/543 • Number of events 16 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.2%
7/585 • Number of events 18 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.7%
16/585 • Number of events 17 • Up to 5 years
|
4.4%
24/543 • Number of events 35 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.0%
6/585 • Number of events 7 • Up to 5 years
|
1.1%
6/543 • Number of events 11 • Up to 5 years
|
|
Gastrointestinal disorders
Ileal fistula
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Ileus
|
1.5%
9/585 • Number of events 9 • Up to 5 years
|
2.2%
12/543 • Number of events 13 • Up to 5 years
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
42.1%
246/585 • Number of events 647 • Up to 5 years
|
21.9%
119/543 • Number of events 189 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
74.0%
433/585 • Number of events 1904 • Up to 5 years
|
60.0%
326/543 • Number of events 727 • Up to 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.34%
2/585 • Number of events 4 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
1.7%
9/543 • Number of events 12 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal fistula
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.2%
19/585 • Number of events 31 • Up to 5 years
|
2.4%
13/543 • Number of events 19 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/585 • Up to 5 years
|
1.1%
6/543 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal pain
|
1.4%
8/585 • Number of events 9 • Up to 5 years
|
2.2%
12/543 • Number of events 18 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal perforation
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
7/585 • Number of events 7 • Up to 5 years
|
4.1%
22/543 • Number of events 27 • Up to 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Typhlitis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
188/585 • Number of events 383 • Up to 5 years
|
23.0%
125/543 • Number of events 196 • Up to 5 years
|
|
General disorders
Chills
|
1.5%
9/585 • Number of events 12 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
General disorders
Edema limbs
|
2.1%
12/585 • Number of events 28 • Up to 5 years
|
0.92%
5/543 • Number of events 10 • Up to 5 years
|
|
General disorders
Fatigue
|
91.3%
534/585 • Number of events 3408 • Up to 5 years
|
83.8%
455/543 • Number of events 1605 • Up to 5 years
|
|
General disorders
Fever
|
1.9%
11/585 • Number of events 13 • Up to 5 years
|
0.74%
4/543 • Number of events 5 • Up to 5 years
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.9%
11/585 • Number of events 27 • Up to 5 years
|
1.1%
6/543 • Number of events 9 • Up to 5 years
|
|
General disorders
Localized edema
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
General disorders
Malaise
|
0.34%
2/585 • Number of events 4 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
General disorders
Pain
|
69.2%
405/585 • Number of events 1514 • Up to 5 years
|
75.5%
410/543 • Number of events 1202 • Up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Immune system disorders
Allergic reaction
|
1.2%
7/585 • Number of events 9 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Immune system disorders
Anaphylaxis
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Abdominal infection
|
0.34%
2/585 • Number of events 4 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Anorectal infection
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Appendicitis
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Bladder infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Bone infection
|
0.00%
0/585 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Bronchial infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Catheter related infection
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Conjunctivitis
|
0.17%
1/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/585 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
1.5%
9/585 • Number of events 9 • Up to 5 years
|
1.7%
9/543 • Number of events 10 • Up to 5 years
|
|
Infections and infestations
Sinusitis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Skin infection
|
0.85%
5/585 • Number of events 7 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Stoma site infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Tooth infection
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.4%
8/585 • Number of events 9 • Up to 5 years
|
1.7%
9/543 • Number of events 13 • Up to 5 years
|
|
Infections and infestations
Wound infection
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
1.7%
9/543 • Number of events 9 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
2.2%
12/543 • Number of events 14 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Gastric anastomotic leak
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.92%
5/543 • Number of events 5 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/585 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.51%
3/585 • Number of events 5 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Intestinal stoma leak
|
0.34%
2/585 • Number of events 4 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Intraoperative urinary injury
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Large intestinal anastomotic leak
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Rectal anastomotic leak
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
1.1%
6/543 • Number of events 7 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.85%
5/585 • Number of events 14 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.85%
5/585 • Number of events 5 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
42/585 • Number of events 86 • Up to 5 years
|
1.5%
8/543 • Number of events 13 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
3.1%
18/585 • Number of events 45 • Up to 5 years
|
2.6%
14/543 • Number of events 26 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
44/585 • Number of events 99 • Up to 5 years
|
1.8%
10/543 • Number of events 15 • Up to 5 years
|
|
Investigations
Blood bilirubin increased
|
1.0%
6/585 • Number of events 10 • Up to 5 years
|
1.1%
6/543 • Number of events 7 • Up to 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Investigations
Cholesterol high
|
0.34%
2/585 • Number of events 6 • Up to 5 years
|
0.55%
3/543 • Number of events 5 • Up to 5 years
|
|
Investigations
Creatinine increased
|
3.1%
18/585 • Number of events 30 • Up to 5 years
|
3.1%
17/543 • Number of events 23 • Up to 5 years
|
|
Investigations
ECG QT corrected interval prolonged
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Investigations
Ejection fraction decreased
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Investigations
GGT increased
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Investigations
Hemoglobin increased
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Investigations
INR increased
|
0.34%
2/585 • Number of events 7 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Investigations
Investigations - Other, specify
|
1.0%
6/585 • Number of events 16 • Up to 5 years
|
0.74%
4/543 • Number of events 11 • Up to 5 years
|
|
Investigations
Lipase increased
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
3.6%
21/585 • Number of events 46 • Up to 5 years
|
13.6%
74/543 • Number of events 145 • Up to 5 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Investigations
Neutrophil count decreased
|
27.0%
158/585 • Number of events 277 • Up to 5 years
|
4.4%
24/543 • Number of events 32 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
10.4%
61/585 • Number of events 152 • Up to 5 years
|
4.4%
24/543 • Number of events 34 • Up to 5 years
|
|
Investigations
Weight gain
|
0.51%
3/585 • Number of events 8 • Up to 5 years
|
0.37%
2/543 • Number of events 6 • Up to 5 years
|
|
Investigations
Weight loss
|
3.9%
23/585 • Number of events 41 • Up to 5 years
|
5.0%
27/543 • Number of events 37 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
9.1%
53/585 • Number of events 120 • Up to 5 years
|
6.8%
37/543 • Number of events 48 • Up to 5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
47.4%
277/585 • Number of events 904 • Up to 5 years
|
39.8%
216/543 • Number of events 437 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
20/585 • Number of events 22 • Up to 5 years
|
7.4%
40/543 • Number of events 52 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/585 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
41/585 • Number of events 93 • Up to 5 years
|
4.1%
22/543 • Number of events 40 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.85%
5/585 • Number of events 5 • Up to 5 years
|
1.5%
8/543 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
18/585 • Number of events 39 • Up to 5 years
|
3.5%
19/543 • Number of events 27 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.7%
16/585 • Number of events 24 • Up to 5 years
|
2.8%
15/543 • Number of events 21 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.4%
26/585 • Number of events 34 • Up to 5 years
|
5.2%
28/543 • Number of events 46 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.68%
4/585 • Number of events 10 • Up to 5 years
|
1.5%
8/543 • Number of events 10 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.1%
24/585 • Number of events 38 • Up to 5 years
|
4.8%
26/543 • Number of events 35 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
0.92%
5/543 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
12/585 • Number of events 31 • Up to 5 years
|
1.8%
10/543 • Number of events 24 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
5/585 • Number of events 7 • Up to 5 years
|
1.1%
6/543 • Number of events 6 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.2%
7/585 • Number of events 9 • Up to 5 years
|
2.6%
14/543 • Number of events 20 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.34%
2/585 • Number of events 7 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
1.0%
6/585 • Number of events 9 • Up to 5 years
|
0.37%
2/543 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.85%
5/585 • Number of events 9 • Up to 5 years
|
0.55%
3/543 • Number of events 5 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
6/585 • Number of events 6 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.17%
1/585 • Number of events 6 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia second to oncology chemo
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.17%
1/585 • Number of events 4 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
3.1%
18/585 • Number of events 29 • Up to 5 years
|
2.2%
12/543 • Number of events 17 • Up to 5 years
|
|
Nervous system disorders
Dysesthesia
|
0.68%
4/585 • Number of events 13 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
3.4%
20/585 • Number of events 49 • Up to 5 years
|
2.2%
12/543 • Number of events 15 • Up to 5 years
|
|
Nervous system disorders
Dysphasia
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
2.6%
15/585 • Number of events 29 • Up to 5 years
|
2.0%
11/543 • Number of events 13 • Up to 5 years
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
0.85%
5/585 • Number of events 10 • Up to 5 years
|
0.74%
4/543 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.68%
4/585 • Number of events 8 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
4.1%
24/585 • Number of events 70 • Up to 5 years
|
1.5%
8/543 • Number of events 18 • Up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.85%
5/585 • Number of events 7 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
89.2%
522/585 • Number of events 3697 • Up to 5 years
|
68.1%
370/543 • Number of events 1411 • Up to 5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/585 • Up to 5 years
|
0.37%
2/543 • Number of events 5 • Up to 5 years
|
|
Nervous system disorders
Spasticity
|
0.17%
1/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/585 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
1.9%
11/585 • Number of events 11 • Up to 5 years
|
1.8%
10/543 • Number of events 13 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Tremor
|
0.68%
4/585 • Number of events 15 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
47.2%
276/585 • Number of events 1215 • Up to 5 years
|
37.0%
201/543 • Number of events 609 • Up to 5 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
26.3%
154/585 • Number of events 547 • Up to 5 years
|
24.1%
131/543 • Number of events 343 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
2.9%
17/585 • Number of events 56 • Up to 5 years
|
3.3%
18/543 • Number of events 31 • Up to 5 years
|
|
Psychiatric disorders
Irritability
|
0.17%
1/585 • Number of events 4 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Personality change
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
14/585 • Number of events 18 • Up to 5 years
|
3.1%
17/543 • Number of events 25 • Up to 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.34%
2/585 • Number of events 9 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/585 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.0%
6/585 • Number of events 8 • Up to 5 years
|
2.0%
11/543 • Number of events 15 • Up to 5 years
|
|
Renal and urinary disorders
Renal calculi
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Urinary fistula
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.0%
6/585 • Number of events 10 • Up to 5 years
|
3.3%
18/543 • Number of events 26 • Up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/585 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.85%
5/585 • Number of events 6 • Up to 5 years
|
1.1%
6/543 • Number of events 14 • Up to 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.74%
4/543 • Number of events 5 • Up to 5 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.51%
3/585 • Number of events 4 • Up to 5 years
|
1.7%
9/543 • Number of events 14 • Up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.92%
5/543 • Number of events 6 • Up to 5 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.85%
5/585 • Number of events 9 • Up to 5 years
|
0.92%
5/543 • Number of events 9 • Up to 5 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
12/585 • Number of events 24 • Up to 5 years
|
1.3%
7/543 • Number of events 8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
32.0%
187/585 • Number of events 587 • Up to 5 years
|
21.9%
119/543 • Number of events 251 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
10/585 • Number of events 29 • Up to 5 years
|
0.55%
3/543 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.51%
3/585 • Number of events 6 • Up to 5 years
|
0.55%
3/543 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.74%
4/543 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.68%
4/585 • Number of events 5 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.51%
3/585 • Number of events 8 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
4/585 • Number of events 4 • Up to 5 years
|
1.1%
6/543 • Number of events 8 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.34%
2/585 • Number of events 2 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.17%
1/585 • Number of events 2 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
17/585 • Number of events 49 • Up to 5 years
|
1.3%
7/543 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
3/585 • Number of events 6 • Up to 5 years
|
2.6%
14/543 • Number of events 26 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.34%
2/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.17%
1/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.2%
7/585 • Number of events 12 • Up to 5 years
|
2.8%
15/543 • Number of events 18 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
5/585 • Number of events 9 • Up to 5 years
|
0.74%
4/543 • Number of events 5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.85%
5/585 • Number of events 13 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
13/585 • Number of events 19 • Up to 5 years
|
1.5%
8/543 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.4%
8/585 • Number of events 12 • Up to 5 years
|
1.7%
9/543 • Number of events 11 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.51%
3/585 • Number of events 13 • Up to 5 years
|
1.3%
7/543 • Number of events 8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.17%
1/585 • Number of events 4 • Up to 5 years
|
0.37%
2/543 • Number of events 5 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/585 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Social circumstances
Social circumstances - Other, specify
|
0.17%
1/585 • Number of events 5 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.74%
4/543 • Number of events 4 • Up to 5 years
|
|
Vascular disorders
Flushing
|
0.17%
1/585 • Number of events 1 • Up to 5 years
|
0.18%
1/543 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
0.51%
3/585 • Number of events 3 • Up to 5 years
|
0.00%
0/543 • Up to 5 years
|
|
Vascular disorders
Hot flashes
|
1.0%
6/585 • Number of events 9 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
10.3%
60/585 • Number of events 154 • Up to 5 years
|
8.8%
48/543 • Number of events 104 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
3.2%
19/585 • Number of events 24 • Up to 5 years
|
2.9%
16/543 • Number of events 20 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
3.4%
20/585 • Number of events 33 • Up to 5 years
|
2.4%
13/543 • Number of events 14 • Up to 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.51%
3/585 • Number of events 7 • Up to 5 years
|
0.37%
2/543 • Number of events 2 • Up to 5 years
|
Additional Information
Dr.Deborah Schrag
Memorial Sloan Kettering Cancer Center
Phone: 617-416-5194
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place