Trial Outcomes & Findings for Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer (NCT NCT00381706)
NCT ID: NCT00381706
Last Updated: 2021-09-29
Results Overview
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Up to 2 years post-treatment
Results posted on
2021-09-29
Participant Flow
Between September 2006 and May 2009, 245 participants were enrolled and randomized.
Twenty three (23) participants had squamous cell carcinoma were excluded from the analysis.
Participant milestones
| Measure |
Arm A (ECF + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B (IC + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
ARM C (FOLFOX + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
80
|
|
Overall Study
COMPLETED
|
75
|
81
|
79
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A (ECF + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B (IC + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
ARM C (FOLFOX + Cetuximab)
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Never treated
|
7
|
2
|
1
|
Baseline Characteristics
Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)
n=8 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)
n=8 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)
n=6 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
n=39 Participants
|
60.3 years
n=41 Participants
|
59.2 years
n=35 Participants
|
61.6 years
n=31 Participants
|
61.8 years
n=146 Participants
|
61.2 years
n=19 Participants
|
59.3 years
n=147 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
32 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
203 Participants
n=147 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
9 Participants
n=147 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=39 Participants
|
69 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
223 Participants
n=147 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=39 Participants
|
73 participants
n=41 Participants
|
73 participants
n=35 Participants
|
8 participants
n=31 Participants
|
8 participants
n=146 Participants
|
6 participants
n=19 Participants
|
235 participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years post-treatmentPopulation: 13 participants did not meet the protocol defined requirements to be evaluated for response (measurable adencarcinoma receiving at least 1 cycle of chemotherapy).
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.
Outcome measures
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=63 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=71 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=66 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
|
61 percentage of participants
Interval 48.0 to 72.0
|
45 percentage of participants
Interval 33.0 to 57.0
|
54 percentage of participants
Interval 42.0 to 66.0
|
SECONDARY outcome
Timeframe: Up to 2 years post-treatmentPopulation: 4 participants did not meet the protocol defined requirements to be evaluated for response (measurable squamous cell carcinoma receiving at least 1 cycle of chemotherapy).
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with squamous cell carcinoma who have received at least one cycle of therapy.
Outcome measures
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=6 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=8 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=5 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
|
67 percentage of participants
|
13 percentage of participants
|
60 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 years post-treatmentOverall survival (OS) was defined as the time from study entry to death of any cause. The median OS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival in Patients With Adenocarcinoma
|
11.6 months
Interval 8.1 to 13.4
|
8.6 months
Interval 6.0 to 12.4
|
11.8 months
Interval 8.8 to 13.9
|
SECONDARY outcome
Timeframe: Up to 2 years post-treatmentProgression free survival (PFS) was defined as the time from study entry to progression or death of any cause. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression-free Survival in Patients With Adenocarcinoma
|
7.1 months
Interval 4.5 to 8.4
|
4.9 months
Interval 3.9 to 6.0
|
6.8 months
Interval 5.4 to 8.1
|
SECONDARY outcome
Timeframe: Up to 2 years post-treatmentTime to treatment failure (TTF) was measured from study entry until documented progression, death resulting from any cause, or end of protocol therapy because of unacceptable toxicity. The median TTF with 95% CI was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 Participants
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Treatment Failure in Patients With Adenocarcinoma
|
5.6 months
Interval 3.9 to 7.2
|
4.3 months
Interval 3.6 to 5.5
|
6.7 months
Interval 4.8 to 7.4
|
Adverse Events
Arm A: Adenocarcinoma (ECF + Cetuximab)
Serious events: 15 serious events
Other events: 65 other events
Deaths: 0 deaths
Arm B: Adenocarcinoma (IC + Cetuximab)
Serious events: 23 serious events
Other events: 68 other events
Deaths: 0 deaths
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
Serious events: 22 serious events
Other events: 71 other events
Deaths: 0 deaths
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)
n=8 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)
n=8 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)
n=6 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/67 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
10.4%
7/67 • Number of events 11
|
16.4%
12/73 • Number of events 12
|
12.3%
9/73 • Number of events 10
|
25.0%
2/8 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Edema
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Eye disorder
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
5.5%
4/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/67
|
2.7%
2/73 • Number of events 3
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
4.5%
3/67 • Number of events 3
|
4.1%
3/73 • Number of events 4
|
1.4%
1/73 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
3/67 • Number of events 3
|
20.5%
15/73 • Number of events 17
|
11.0%
8/73 • Number of events 8
|
25.0%
2/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/67
|
0.00%
0/73
|
4.1%
3/73 • Number of events 3
|
12.5%
1/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.0%
2/67 • Number of events 2
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
1.5%
1/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
3/67 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
6.8%
5/73 • Number of events 5
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
7.5%
5/67 • Number of events 6
|
11.0%
8/73 • Number of events 9
|
5.5%
4/73 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomach pain
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
6/67 • Number of events 6
|
11.0%
8/73 • Number of events 10
|
12.3%
9/73 • Number of events 9
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 3
|
|
General disorders
Chest pain
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chills
|
1.5%
1/67 • Number of events 2
|
4.1%
3/73 • Number of events 3
|
4.1%
3/73 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Disease progression
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Edema limbs
|
1.5%
1/67 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Fatigue
|
13.4%
9/67 • Number of events 12
|
26.0%
19/73 • Number of events 21
|
20.5%
15/73 • Number of events 18
|
25.0%
2/8 • Number of events 4
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fever
|
1.5%
1/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Sudden death
|
3.0%
2/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Catheter related infection
|
3.0%
2/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Jejunal infection
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/67
|
4.1%
3/73 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase increased
|
1.5%
1/67 • Number of events 1
|
5.5%
4/73 • Number of events 4
|
4.1%
3/73 • Number of events 3
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Amylase increased
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
5.5%
4/73 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/67
|
5.5%
4/73 • Number of events 4
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Coagulopathy
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Creatinine increased
|
4.5%
3/67 • Number of events 4
|
4.1%
3/73 • Number of events 3
|
5.5%
4/73 • Number of events 4
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
INR increased
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Laboratory test abnormal
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Leukocyte count decreased
|
9.0%
6/67 • Number of events 7
|
11.0%
8/73 • Number of events 8
|
6.8%
5/73 • Number of events 5
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Lipase increased
|
0.00%
0/67
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Lymphocyte count decreased
|
3.0%
2/67 • Number of events 3
|
6.8%
5/73 • Number of events 5
|
5.5%
4/73 • Number of events 5
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
14.9%
10/67 • Number of events 12
|
19.2%
14/73 • Number of events 16
|
9.6%
7/73 • Number of events 7
|
25.0%
2/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Platelet count decreased
|
6.0%
4/67 • Number of events 5
|
9.6%
7/73 • Number of events 7
|
9.6%
7/73 • Number of events 8
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Weight loss
|
3.0%
2/67 • Number of events 2
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
6.0%
4/67 • Number of events 5
|
9.6%
7/73 • Number of events 8
|
8.2%
6/73 • Number of events 6
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
6.0%
4/67 • Number of events 4
|
11.0%
8/73 • Number of events 9
|
8.2%
6/73 • Number of events 7
|
12.5%
1/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
6.0%
4/67 • Number of events 4
|
6.8%
5/73 • Number of events 5
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
6.0%
4/67 • Number of events 5
|
15.1%
11/73 • Number of events 12
|
15.1%
11/73 • Number of events 11
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
6.0%
4/67 • Number of events 4
|
9.6%
7/73 • Number of events 7
|
9.6%
7/73 • Number of events 8
|
12.5%
1/8 • Number of events 3
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.0%
4/67 • Number of events 5
|
16.4%
12/73 • Number of events 13
|
12.3%
9/73 • Number of events 10
|
25.0%
2/8 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
1.5%
1/67 • Number of events 1
|
5.5%
4/73 • Number of events 4
|
2.7%
2/73 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
6.0%
4/67 • Number of events 4
|
9.6%
7/73 • Number of events 8
|
9.6%
7/73 • Number of events 7
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.5%
1/67 • Number of events 2
|
12.3%
9/73 • Number of events 9
|
6.8%
5/73 • Number of events 6
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
3.0%
2/67 • Number of events 3
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
3/67 • Number of events 4
|
4.1%
3/73 • Number of events 4
|
12.3%
9/73 • Number of events 10
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
1.5%
1/67 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Syncope vasovagal
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Confusion
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
3/67 • Number of events 3
|
6.8%
5/73 • Number of events 5
|
8.2%
6/73 • Number of events 6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
3/67 • Number of events 3
|
4.1%
3/73 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/67 • Number of events 2
|
4.1%
3/73 • Number of events 4
|
0.00%
0/73
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.0%
2/67 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/67
|
2.7%
2/73 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.0%
4/67 • Number of events 4
|
12.3%
9/73 • Number of events 9
|
11.0%
8/73 • Number of events 10
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
1.5%
1/67 • Number of events 2
|
4.1%
3/73 • Number of events 3
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
3.0%
2/67 • Number of events 2
|
5.5%
4/73 • Number of events 4
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
4.5%
3/67 • Number of events 3
|
11.0%
8/73 • Number of events 8
|
9.6%
7/73 • Number of events 8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
Other adverse events
| Measure |
Arm A: Adenocarcinoma (ECF + Cetuximab)
n=67 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Adenocarcinoma (IC + Cetuximab)
n=73 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Adenocarcinoma (FOLFOX + Cetuximab)
n=73 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)
n=8 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm B: Squamous Cell Carcinoma (IC + Cetuximab)
n=8 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
|
Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)
n=6 participants at risk
Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
3.0%
2/67 • Number of events 36
|
1.4%
1/73 • Number of events 3
|
2.7%
2/73 • Number of events 21
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
3/67 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
70.1%
47/67 • Number of events 264
|
76.7%
56/73 • Number of events 312
|
67.1%
49/73 • Number of events 326
|
62.5%
5/8 • Number of events 25
|
50.0%
4/8 • Number of events 16
|
66.7%
4/6 • Number of events 35
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.0%
2/67 • Number of events 3
|
5.5%
4/73 • Number of events 10
|
2.7%
2/73 • Number of events 13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/67
|
1.4%
1/73 • Number of events 3
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Conduction disorder
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Edema
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.0%
2/67 • Number of events 5
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Left ventricular failure
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/67
|
0.00%
0/73
|
4.1%
3/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Sinus tachycardia
|
3.0%
2/67 • Number of events 4
|
0.00%
0/73
|
2.7%
2/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Ear disorder
|
1.5%
1/67 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.0%
2/67 • Number of events 15
|
9.6%
7/73 • Number of events 10
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Tinnitus
|
9.0%
6/67 • Number of events 8
|
6.8%
5/73 • Number of events 17
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/67
|
1.4%
1/73 • Number of events 12
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Conjunctivitis
|
1.5%
1/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Diplopia
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Dry eye syndrome
|
3.0%
2/67 • Number of events 4
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Eye disorder
|
4.5%
3/67 • Number of events 6
|
0.00%
0/73
|
4.1%
3/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Eyelid function disorder
|
1.5%
1/67 • Number of events 2
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Flashing vision
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Photophobia
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
1.5%
1/67 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Watering eyes
|
4.5%
3/67 • Number of events 7
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 6
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
3.0%
2/67 • Number of events 2
|
5.5%
4/73 • Number of events 4
|
4.1%
3/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
20.9%
14/67 • Number of events 30
|
35.6%
26/73 • Number of events 66
|
19.2%
14/73 • Number of events 27
|
25.0%
2/8 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
56.7%
38/67 • Number of events 102
|
53.4%
39/73 • Number of events 94
|
52.1%
38/73 • Number of events 137
|
62.5%
5/8 • Number of events 6
|
25.0%
2/8 • Number of events 3
|
33.3%
2/6 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
52.2%
35/67 • Number of events 85
|
74.0%
54/73 • Number of events 175
|
61.6%
45/73 • Number of events 162
|
62.5%
5/8 • Number of events 9
|
62.5%
5/8 • Number of events 6
|
66.7%
4/6 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
4/67 • Number of events 11
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
14.9%
10/67 • Number of events 15
|
9.6%
7/73 • Number of events 12
|
15.1%
11/73 • Number of events 23
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
32.8%
22/67 • Number of events 47
|
24.7%
18/73 • Number of events 45
|
19.2%
14/73 • Number of events 51
|
37.5%
3/8 • Number of events 8
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 4
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
44.8%
30/67 • Number of events 82
|
16.4%
12/73 • Number of events 26
|
24.7%
18/73 • Number of events 54
|
50.0%
4/8 • Number of events 11
|
0.00%
0/8
|
33.3%
2/6 • Number of events 13
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal mucositis
|
1.5%
1/67 • Number of events 2
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/67
|
4.1%
3/73 • Number of events 4
|
1.4%
1/73 • Number of events 6
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Esophagitis
|
11.9%
8/67 • Number of events 13
|
4.1%
3/73 • Number of events 4
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
3/67 • Number of events 3
|
0.00%
0/73
|
2.7%
2/73 • Number of events 14
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.5%
1/67 • Number of events 4
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 3
|
1.4%
1/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.0%
2/67 • Number of events 2
|
5.5%
4/73 • Number of events 6
|
5.5%
4/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.5%
1/67 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucositis oral
|
44.8%
30/67 • Number of events 81
|
16.4%
12/73 • Number of events 25
|
39.7%
29/73 • Number of events 94
|
25.0%
2/8 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
33.3%
2/6 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
71.6%
48/67 • Number of events 164
|
74.0%
54/73 • Number of events 151
|
57.5%
42/73 • Number of events 175
|
87.5%
7/8 • Number of events 17
|
37.5%
3/8 • Number of events 6
|
83.3%
5/6 • Number of events 16
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
3.0%
2/67 • Number of events 3
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.5%
1/67 • Number of events 3
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Oral pain
|
3.0%
2/67 • Number of events 5
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Proctoscopy abnormal
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.0%
2/67 • Number of events 2
|
4.1%
3/73 • Number of events 5
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Rectal pain
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomach pain
|
1.5%
1/67 • Number of events 2
|
5.5%
4/73 • Number of events 6
|
9.6%
7/73 • Number of events 12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Tooth disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
43.3%
29/67 • Number of events 65
|
46.6%
34/73 • Number of events 84
|
45.2%
33/73 • Number of events 61
|
50.0%
4/8 • Number of events 10
|
50.0%
4/8 • Number of events 4
|
66.7%
4/6 • Number of events 10
|
|
General disorders
Chest pain
|
11.9%
8/67 • Number of events 9
|
5.5%
4/73 • Number of events 4
|
9.6%
7/73 • Number of events 23
|
12.5%
1/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Chills
|
11.9%
8/67 • Number of events 12
|
16.4%
12/73 • Number of events 21
|
19.2%
14/73 • Number of events 27
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Edema limbs
|
10.4%
7/67 • Number of events 10
|
19.2%
14/73 • Number of events 24
|
12.3%
9/73 • Number of events 17
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Facial pain
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Fatigue
|
94.0%
63/67 • Number of events 318
|
89.0%
65/73 • Number of events 330
|
83.6%
61/73 • Number of events 558
|
100.0%
8/8 • Number of events 44
|
75.0%
6/8 • Number of events 8
|
83.3%
5/6 • Number of events 23
|
|
General disorders
Fever
|
6.0%
4/67 • Number of events 6
|
6.8%
5/73 • Number of events 6
|
15.1%
11/73 • Number of events 12
|
0.00%
0/8
|
0.00%
0/8
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Flu-like symptoms
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
General symptom
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Ill-defined disorder
|
0.00%
0/67
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Injection site reaction
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 7
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Localized edema
|
1.5%
1/67 • Number of events 2
|
4.1%
3/73 • Number of events 5
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Pain
|
17.9%
12/67 • Number of events 19
|
8.2%
6/73 • Number of events 10
|
8.2%
6/73 • Number of events 17
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
33.3%
2/6 • Number of events 5
|
|
General disorders
Visceral edema
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
11.9%
8/67 • Number of events 9
|
6.8%
5/73 • Number of events 7
|
9.6%
7/73 • Number of events 7
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Bronchitis
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Catheter related infection
|
9.0%
6/67 • Number of events 7
|
2.7%
2/73 • Number of events 4
|
1.4%
1/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Conjunctivitis infective
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Corneal infection
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Device related infection
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Eye infection
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Gingival infection
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Infection
|
7.5%
5/67 • Number of events 7
|
0.00%
0/73
|
4.1%
3/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Infection without neutropenia
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 4
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Lip infection
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/67
|
2.7%
2/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Nail infection
|
7.5%
5/67 • Number of events 10
|
4.1%
3/73 • Number of events 4
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 13
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Otitis externa
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Otitis media
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Sepsis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
4.5%
3/67 • Number of events 4
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Skin infection
|
7.5%
5/67 • Number of events 6
|
5.5%
4/73 • Number of events 6
|
4.1%
3/73 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory infection
|
1.5%
1/67 • Number of events 2
|
5.5%
4/73 • Number of events 5
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Infections and infestations
Wound infection
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.5%
3/67 • Number of events 4
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.5%
1/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/67
|
0.00%
0/73
|
2.7%
2/73 • Number of events 4
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
13.4%
9/67 • Number of events 17
|
31.5%
23/73 • Number of events 47
|
23.3%
17/73 • Number of events 59
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase
|
1.5%
1/67 • Number of events 4
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Alkaline phosphatase increased
|
22.4%
15/67 • Number of events 36
|
32.9%
24/73 • Number of events 62
|
32.9%
24/73 • Number of events 92
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 7
|
33.3%
2/6 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
20.9%
14/67 • Number of events 19
|
28.8%
21/73 • Number of events 34
|
37.0%
27/73 • Number of events 91
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 3
|
16.7%
1/6 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/67 • Number of events 2
|
8.2%
6/73 • Number of events 8
|
5.5%
4/73 • Number of events 26
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Creatinine increased
|
26.9%
18/67 • Number of events 57
|
15.1%
11/73 • Number of events 32
|
4.1%
3/73 • Number of events 3
|
25.0%
2/8 • Number of events 4
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
INR increased
|
3.0%
2/67 • Number of events 6
|
2.7%
2/73 • Number of events 3
|
5.5%
4/73 • Number of events 40
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
7.5%
5/67 • Number of events 43
|
1.4%
1/73 • Number of events 1
|
4.1%
3/73 • Number of events 3
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Leukocyte count decreased
|
56.7%
38/67 • Number of events 158
|
53.4%
39/73 • Number of events 165
|
45.2%
33/73 • Number of events 228
|
25.0%
2/8 • Number of events 2
|
25.0%
2/8 • Number of events 10
|
50.0%
3/6 • Number of events 8
|
|
Investigations
Lipase increased
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Lymphocyte count decreased
|
13.4%
9/67 • Number of events 47
|
17.8%
13/73 • Number of events 54
|
15.1%
11/73 • Number of events 107
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 5
|
16.7%
1/6 • Number of events 5
|
|
Investigations
Lymphopenia for pediatric BMT studies
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
76.1%
51/67 • Number of events 228
|
63.0%
46/73 • Number of events 192
|
54.8%
40/73 • Number of events 198
|
87.5%
7/8 • Number of events 33
|
62.5%
5/8 • Number of events 16
|
66.7%
4/6 • Number of events 6
|
|
Investigations
Platelet count decreased
|
37.3%
25/67 • Number of events 74
|
39.7%
29/73 • Number of events 115
|
43.8%
32/73 • Number of events 239
|
37.5%
3/8 • Number of events 14
|
37.5%
3/8 • Number of events 6
|
33.3%
2/6 • Number of events 7
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/67
|
0.00%
0/73
|
5.5%
4/73 • Number of events 10
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Weight gain
|
3.0%
2/67 • Number of events 2
|
2.7%
2/73 • Number of events 2
|
4.1%
3/73 • Number of events 5
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Weight loss
|
22.4%
15/67 • Number of events 27
|
32.9%
24/73 • Number of events 53
|
24.7%
18/73 • Number of events 64
|
25.0%
2/8 • Number of events 2
|
37.5%
3/8 • Number of events 12
|
33.3%
2/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
49.3%
33/67 • Number of events 102
|
46.6%
34/73 • Number of events 88
|
47.9%
35/73 • Number of events 130
|
50.0%
4/8 • Number of events 7
|
37.5%
3/8 • Number of events 3
|
33.3%
2/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
1.5%
1/67 • Number of events 1
|
2.7%
2/73 • Number of events 4
|
4.1%
3/73 • Number of events 5
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
46.3%
31/67 • Number of events 145
|
52.1%
38/73 • Number of events 154
|
42.5%
31/73 • Number of events 225
|
37.5%
3/8 • Number of events 16
|
25.0%
2/8 • Number of events 2
|
50.0%
3/6 • Number of events 24
|
|
Metabolism and nutrition disorders
Dehydration
|
25.4%
17/67 • Number of events 39
|
38.4%
28/73 • Number of events 61
|
19.2%
14/73 • Number of events 34
|
37.5%
3/8 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
26.9%
18/67 • Number of events 59
|
47.9%
35/73 • Number of events 136
|
42.5%
31/73 • Number of events 145
|
12.5%
1/8 • Number of events 13
|
62.5%
5/8 • Number of events 11
|
50.0%
3/6 • Number of events 33
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
32.8%
22/67 • Number of events 53
|
37.0%
27/73 • Number of events 78
|
24.7%
18/73 • Number of events 69
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 11
|
50.0%
3/6 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.0%
2/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
8.2%
6/73 • Number of events 12
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
1.5%
1/67 • Number of events 1
|
6.8%
5/73 • Number of events 5
|
9.6%
7/73 • Number of events 11
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
59.7%
40/67 • Number of events 180
|
69.9%
51/73 • Number of events 255
|
52.1%
38/73 • Number of events 238
|
62.5%
5/8 • Number of events 34
|
50.0%
4/8 • Number of events 15
|
50.0%
3/6 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.5%
3/67 • Number of events 3
|
6.8%
5/73 • Number of events 9
|
4.1%
3/73 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
32.8%
22/67 • Number of events 61
|
39.7%
29/73 • Number of events 77
|
42.5%
31/73 • Number of events 91
|
12.5%
1/8 • Number of events 4
|
25.0%
2/8 • Number of events 7
|
50.0%
3/6 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.5%
3/67 • Number of events 5
|
8.2%
6/73 • Number of events 9
|
9.6%
7/73 • Number of events 13
|
37.5%
3/8 • Number of events 6
|
0.00%
0/8
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
38.8%
26/67 • Number of events 62
|
46.6%
34/73 • Number of events 79
|
35.6%
26/73 • Number of events 60
|
0.00%
0/8
|
37.5%
3/8 • Number of events 7
|
50.0%
3/6 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
7/67 • Number of events 12
|
6.8%
5/73 • Number of events 18
|
4.1%
3/73 • Number of events 29
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
7/67 • Number of events 13
|
16.4%
12/73 • Number of events 22
|
16.4%
12/73 • Number of events 27
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.5%
1/67 • Number of events 3
|
2.7%
2/73 • Number of events 6
|
5.5%
4/73 • Number of events 7
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/67
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.0%
4/67 • Number of events 7
|
6.8%
5/73 • Number of events 8
|
1.4%
1/73 • Number of events 2
|
25.0%
2/8 • Number of events 9
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.0%
4/67 • Number of events 5
|
8.2%
6/73 • Number of events 11
|
5.5%
4/73 • Number of events 8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.5%
3/67 • Number of events 3
|
2.7%
2/73 • Number of events 2
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/67
|
4.1%
3/73 • Number of events 4
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
4/67 • Number of events 10
|
8.2%
6/73 • Number of events 11
|
5.5%
4/73 • Number of events 8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.0%
4/67 • Number of events 7
|
2.7%
2/73 • Number of events 5
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
5/67 • Number of events 13
|
6.8%
5/73 • Number of events 8
|
9.6%
7/73 • Number of events 51
|
0.00%
0/8
|
12.5%
1/8 • Number of events 3
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.5%
3/67 • Number of events 7
|
1.4%
1/73 • Number of events 2
|
5.5%
4/73 • Number of events 4
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain (onset or exacerbation of tumor pain due to treatment)
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Ataxia
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 2
|
2.7%
2/73 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
16.4%
11/67 • Number of events 24
|
17.8%
13/73 • Number of events 26
|
17.8%
13/73 • Number of events 18
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
19.4%
13/67 • Number of events 26
|
15.1%
11/73 • Number of events 31
|
26.0%
19/73 • Number of events 111
|
37.5%
3/8 • Number of events 4
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
9.0%
6/67 • Number of events 9
|
2.7%
2/73 • Number of events 4
|
6.8%
5/73 • Number of events 9
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.0%
2/67 • Number of events 2
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Neurological disorder NOS
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 2
|
2.7%
2/73 • Number of events 2
|
12.5%
1/8 • Number of events 7
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Oculomotor nerve disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.0%
2/67 • Number of events 5
|
1.4%
1/73 • Number of events 4
|
5.5%
4/73 • Number of events 13
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
41.8%
28/67 • Number of events 117
|
41.1%
30/73 • Number of events 108
|
82.2%
60/73 • Number of events 515
|
75.0%
6/8 • Number of events 14
|
12.5%
1/8 • Number of events 3
|
16.7%
1/6 • Number of events 22
|
|
Nervous system disorders
Seizure
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Speech disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
3.0%
2/67 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Syncope vasovagal
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
3.0%
2/67 • Number of events 2
|
2.7%
2/73 • Number of events 9
|
2.7%
2/73 • Number of events 7
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Agitation
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
9.0%
6/67 • Number of events 15
|
5.5%
4/73 • Number of events 7
|
9.6%
7/73 • Number of events 31
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
1.5%
1/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
14.9%
10/67 • Number of events 17
|
6.8%
5/73 • Number of events 7
|
11.0%
8/73 • Number of events 19
|
12.5%
1/8 • Number of events 4
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
14.9%
10/67 • Number of events 22
|
17.8%
13/73 • Number of events 33
|
20.5%
15/73 • Number of events 49
|
0.00%
0/8
|
0.00%
0/8
|
50.0%
3/6 • Number of events 4
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 6
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/67
|
0.00%
0/73
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
1.5%
1/67 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Hematuria (absence of vaginal bleeding)
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Kidney pain
|
3.0%
2/67 • Number of events 4
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Proteinuria
|
3.0%
2/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal hemorrhage
|
1.5%
1/67 • Number of events 3
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary frequency
|
3.0%
2/67 • Number of events 12
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 11
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.0%
4/67 • Number of events 6
|
8.2%
6/73 • Number of events 18
|
5.5%
4/73 • Number of events 6
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.5%
1/67 • Number of events 3
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
13/67 • Number of events 36
|
20.5%
15/73 • Number of events 31
|
20.5%
15/73 • Number of events 45
|
25.0%
2/8 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.9%
18/67 • Number of events 38
|
27.4%
20/73 • Number of events 49
|
24.7%
18/73 • Number of events 75
|
25.0%
2/8 • Number of events 5
|
0.00%
0/8
|
16.7%
1/6 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/67
|
4.1%
3/73 • Number of events 4
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.9%
8/67 • Number of events 12
|
5.5%
4/73 • Number of events 4
|
15.1%
11/73 • Number of events 40
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.5%
3/67 • Number of events 3
|
4.1%
3/73 • Number of events 4
|
5.5%
4/73 • Number of events 12
|
0.00%
0/8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/67 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/67 • Number of events 3
|
4.1%
3/73 • Number of events 5
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
3.0%
2/67 • Number of events 3
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.5%
3/67 • Number of events 5
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/67 • Number of events 3
|
2.7%
2/73 • Number of events 2
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
1.4%
1/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/67
|
0.00%
0/73
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.0%
6/67 • Number of events 19
|
2.7%
2/73 • Number of events 3
|
2.7%
2/73 • Number of events 5
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.7%
36/67 • Number of events 129
|
34.2%
25/73 • Number of events 92
|
32.9%
24/73 • Number of events 117
|
87.5%
7/8 • Number of events 19
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
32.8%
22/67 • Number of events 58
|
21.9%
16/73 • Number of events 40
|
23.3%
17/73 • Number of events 75
|
37.5%
3/8 • Number of events 18
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
31.3%
21/67 • Number of events 53
|
15.1%
11/73 • Number of events 21
|
26.0%
19/73 • Number of events 113
|
37.5%
3/8 • Number of events 9
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
19.4%
13/67 • Number of events 26
|
11.0%
8/73 • Number of events 18
|
16.4%
12/73 • Number of events 63
|
12.5%
1/8 • Number of events 3
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/67
|
1.4%
1/73 • Number of events 1
|
2.7%
2/73 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/67
|
1.4%
1/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.0%
6/67 • Number of events 11
|
8.2%
6/73 • Number of events 11
|
21.9%
16/73 • Number of events 89
|
12.5%
1/8 • Number of events 8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
62.7%
42/67 • Number of events 201
|
67.1%
49/73 • Number of events 219
|
67.1%
49/73 • Number of events 530
|
62.5%
5/8 • Number of events 35
|
50.0%
4/8 • Number of events 5
|
50.0%
3/6 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
31.3%
21/67 • Number of events 84
|
21.9%
16/73 • Number of events 59
|
34.2%
25/73 • Number of events 147
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
33.3%
2/6 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
10.4%
7/67 • Number of events 11
|
8.2%
6/73 • Number of events 9
|
11.0%
8/73 • Number of events 26
|
12.5%
1/8 • Number of events 7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.0%
2/67 • Number of events 5
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
2/67 • Number of events 2
|
4.1%
3/73 • Number of events 3
|
2.7%
2/73 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hematoma
|
0.00%
0/67
|
0.00%
0/73
|
1.4%
1/73 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hemorrhage
|
1.5%
1/67 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hot flashes
|
1.5%
1/67 • Number of events 3
|
1.4%
1/73 • Number of events 2
|
0.00%
0/73
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 2
|
2.7%
2/73 • Number of events 2
|
1.4%
1/73 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
9.0%
6/67 • Number of events 6
|
15.1%
11/73 • Number of events 25
|
5.5%
4/73 • Number of events 12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
33.3%
2/6 • Number of events 7
|
|
Vascular disorders
Phlebitis
|
1.5%
1/67 • Number of events 1
|
0.00%
0/73
|
0.00%
0/73
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Vascular disorders
Thrombosis
|
7.5%
5/67 • Number of events 5
|
13.7%
10/73 • Number of events 12
|
9.6%
7/73 • Number of events 18
|
12.5%
1/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60