Trial Outcomes & Findings for Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer (NCT NCT00613626)
NCT ID: NCT00613626
Last Updated: 2020-02-11
Results Overview
Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
24 months
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
Arm A: ZD6474 Matched Placebo
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
Safety Lead-In
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
7
|
|
Overall Study
1st Dose ZD6474
|
33
|
34
|
7
|
|
Overall Study
COMPLETED
|
33
|
33
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A: ZD6474 Matched Placebo
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
Safety Lead-In
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|---|
|
Overall Study
Ineligible
|
0
|
1
|
0
|
Baseline Characteristics
Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
Safety Lead-In
n=7 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.58 years
STANDARD_DEVIATION 10.92 • n=93 Participants
|
63.80 years
STANDARD_DEVIATION 5.90 • n=4 Participants
|
66.14 years
STANDARD_DEVIATION 3.34 • n=27 Participants
|
62.94 years
STANDARD_DEVIATION 8.83 • n=483 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
67 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
33 participants
n=4 Participants
|
7 participants
n=27 Participants
|
73 participants
n=483 Participants
|
|
ECOG Performance Status
0
|
12 participants
n=93 Participants
|
11 participants
n=4 Participants
|
2 participants
n=27 Participants
|
25 participants
n=483 Participants
|
|
ECOG Performance Status
1
|
21 participants
n=93 Participants
|
22 participants
n=4 Participants
|
5 participants
n=27 Participants
|
48 participants
n=483 Participants
|
|
Liver Metastases
Present
|
16 participants
n=93 Participants
|
13 participants
n=4 Participants
|
1 participants
n=27 Participants
|
30 participants
n=483 Participants
|
|
Liver Metastases
Absent
|
17 participants
n=93 Participants
|
20 participants
n=4 Participants
|
6 participants
n=27 Participants
|
43 participants
n=483 Participants
|
|
Brain Metastases
Present
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
5 participants
n=27 Participants
|
25 participants
n=483 Participants
|
|
Brain Metastases
Absent
|
23 participants
n=93 Participants
|
23 participants
n=4 Participants
|
2 participants
n=27 Participants
|
48 participants
n=483 Participants
|
|
Platinum Therapy
Cisplatin
|
17 participants
n=93 Participants
|
17 participants
n=4 Participants
|
7 participants
n=27 Participants
|
41 participants
n=483 Participants
|
|
Platinum Therapy
Carboplatin
|
16 participants
n=93 Participants
|
16 participants
n=4 Participants
|
0 participants
n=27 Participants
|
32 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)
Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.
Outcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=31 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=31 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Time to Disease Progression - Median Time to Progression and Log-Rank Test
|
5.68 Months
Interval 3.98 to 6.41
|
5.62 Months
Interval 5.09 to 6.24
|
SECONDARY outcome
Timeframe: 6 weeks (2 Cycles)Population: The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.
Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.
Outcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=40 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities
Grade 3/4 Hematologic Toxicity
|
11.00 percentage of participants
|
13.75 percentage of participants
|
|
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities
Grade 3/4 Non-Hematologic Toxicity
|
2.71 percentage of participants
|
4.30 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 12 participants are excluded due to missing data.
Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=26 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=28 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Measure the Response Rate (CR + PR) in Each Arm
|
65.38 percentage of participants
Interval 47.1 to 83.67
|
50.00 percentage of participants
Interval 31.48 to 68.52
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 12 participants were not analyzed due to missing data.
Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( \>=20% increase in the sum of the longest diameter of the target lesions).
Outcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=26 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=28 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Measure Disease Control Rate (CR + PR+ SD) in Each Arm
|
73.08 percentage of participants
Interval 56.03 to 90.13
|
75.00 percentage of participants
Interval 58.96 to 91.04
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Measure Overall Survival for Each Arm
|
9.23 Months
Interval 6.64 to 11.27
|
13.24 Months
Interval 7.82 to 17.38
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: This data was not collected for the safety lead-in participants.
Outcome measures
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=33 Participants
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Survival Analysis VEGF SNP rs699947
|
0.4642 probability
|
0.6148 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Survival Analysis VEGF SNP rs3025039
|
0.1234 probability
|
0.2050 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Survival Analysis VEGF SNP rs2019063
|
0.3968 probability
|
0.8486 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Survival Analysis VEGF SNP rs1570360
|
0.0712 probability
|
0.4426 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Response Analysis VEGF rs699947
|
0.6034 probability
|
0.6034 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Survival Analysis VEGF SNP rs833061
|
0.4642 probability
|
0.6148 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Response Analysis VEGF SNP rs3025039
|
0.1842 probability
|
0.1842 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Response Analysis VEGF SNP rs2019063
|
0.0959 probability
|
0.0959 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Response Analysis VEGF SNP rs1570360
|
0.4586 probability
|
0.4586 probability
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Response Analysis VEGF SNP rs833061
|
0.6034 probability
|
0.6034 probability
|
Adverse Events
Arm A: ZD6474 Matched Placebo
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Arm B: ZD6474
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 participants at risk
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=41 participants at risk
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Nervous system disorders
CONFUSION
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / LOWER GI NOS
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / BRONCHOPULMONARY NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ARTERY
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / MEDIASTINUM NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / BACK
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Hepatobiliary disorders
PANCREATITIS
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Blood and lymphatic system disorders
PLATELETS
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
3.0%
1/33 • Number of events 2
|
0.00%
0/41
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Arm A: ZD6474 Matched Placebo
n=33 participants at risk
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Placebo: Matched placebo oral daily
|
Arm B: ZD6474
n=41 participants at risk
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.
Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
|
|---|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
15.2%
5/33 • Number of events 9
|
12.2%
5/41 • Number of events 5
|
|
Investigations
ALKALINE PHOSPHATASE
|
15.2%
5/33 • Number of events 5
|
9.8%
4/41 • Number of events 5
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
9.1%
3/33 • Number of events 4
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
ANOREXIA
|
33.3%
11/33 • Number of events 12
|
31.7%
13/41 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
18.2%
6/33 • Number of events 6
|
2.4%
1/41 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
9.1%
3/33 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
9.1%
3/33 • Number of events 6
|
14.6%
6/41 • Number of events 9
|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
12.1%
4/33 • Number of events 4
|
4.9%
2/41 • Number of events 2
|
|
Nervous system disorders
CONFUSION
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
27.3%
9/33 • Number of events 12
|
22.0%
9/41 • Number of events 11
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
57.6%
19/33 • Number of events 21
|
29.3%
12/41 • Number of events 13
|
|
Investigations
CREATININE
|
9.1%
3/33 • Number of events 3
|
17.1%
7/41 • Number of events 7
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
DEHYDRATION
|
3.0%
1/33 • Number of events 1
|
9.8%
4/41 • Number of events 6
|
|
Gastrointestinal disorders
DENTAL: TEETH
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
6.1%
2/33 • Number of events 2
|
22.0%
9/41 • Number of events 10
|
|
Nervous system disorders
DIZZINESS
|
6.1%
2/33 • Number of events 8
|
12.2%
5/41 • Number of events 5
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
9.1%
3/33 • Number of events 3
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
54.5%
18/33 • Number of events 22
|
46.3%
19/41 • Number of events 21
|
|
Blood and lymphatic system disorders
EDEMA: HEAD AND NECK
|
9.1%
3/33 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
24.2%
8/33 • Number of events 12
|
4.9%
2/41 • Number of events 2
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
72.7%
24/33 • Number of events 33
|
63.4%
26/41 • Number of events 36
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
9.1%
3/33 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
FLATULENCE
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Eye disorders
GLAUCOMA
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Investigations
GLOMERULAR FILTRATION RATE
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
30.3%
10/33 • Number of events 12
|
22.0%
9/41 • Number of events 13
|
|
Investigations
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
30.3%
10/33 • Number of events 13
|
29.3%
12/41 • Number of events 15
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
6.1%
2/33 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
9.1%
3/33 • Number of events 3
|
14.6%
6/41 • Number of events 6
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
48.5%
16/33 • Number of events 31
|
34.1%
14/41 • Number of events 24
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / UPPER GI NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / RESPIRATORY TRACT NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
6.1%
2/33 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
3.0%
1/33 • Number of events 2
|
0.00%
0/41
|
|
Cardiac disorders
HYPERTENSION
|
18.2%
6/33 • Number of events 6
|
24.4%
10/41 • Number of events 16
|
|
Cardiac disorders
HYPOTENSION
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / MUCOSA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / PHARYNX
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / WOUND
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
INSOMNIA
|
18.2%
6/33 • Number of events 6
|
14.6%
6/41 • Number of events 6
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
21.2%
7/33 • Number of events 11
|
29.3%
12/41 • Number of events 20
|
|
Investigations
LIPASE
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
9.1%
3/33 • Number of events 4
|
4.9%
2/41 • Number of events 2
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
21.2%
7/33 • Number of events 11
|
29.3%
12/41 • Number of events 16
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Investigations
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
21.2%
7/33 • Number of events 7
|
12.2%
5/41 • Number of events 5
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
12.1%
4/33 • Number of events 4
|
9.8%
4/41 • Number of events 4
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
9.1%
3/33 • Number of events 3
|
17.1%
7/41 • Number of events 8
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
6.1%
2/33 • Number of events 2
|
0.00%
0/41
|
|
Gastrointestinal disorders
NAUSEA
|
42.4%
14/33 • Number of events 18
|
39.0%
16/41 • Number of events 17
|
|
Endocrine disorders
NEUROENDOCRINE: ADH SECRETION ABNORMALITY (E.G., SIADH OR LOW ADH)
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Nervous system disorders
NEUROPATHY: CRANIAL / CN V MOTOR-JAW MUSCLES; SENSORY-FACIAL
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
12.1%
4/33 • Number of events 4
|
9.8%
4/41 • Number of events 4
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
33.3%
11/33 • Number of events 17
|
46.3%
19/41 • Number of events 26
|
|
Eye disorders
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
OTITIS, MIDDLE EAR (NON-INFECTIOUS)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
12.1%
4/33 • Number of events 4
|
4.9%
2/41 • Number of events 2
|
|
General disorders
PAIN / BACK
|
30.3%
10/33 • Number of events 10
|
19.5%
8/41 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
General disorders
PAIN / BUTTOCK
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
15.2%
5/33 • Number of events 6
|
9.8%
4/41 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
9.1%
3/33 • Number of events 3
|
14.6%
6/41 • Number of events 7
|
|
Gastrointestinal disorders
PAIN / DENTAL/TEETH/PERIDONTAL
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
9.1%
3/33 • Number of events 4
|
9.8%
4/41 • Number of events 5
|
|
General disorders
PAIN / FACE
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / HEAD/HEADACHE
|
18.2%
6/33 • Number of events 6
|
12.2%
5/41 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
12.1%
4/33 • Number of events 4
|
7.3%
3/41 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
General disorders
PAIN / NECK
|
12.1%
4/33 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / ORAL CAVITY
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
General disorders
PAIN / PAIN NOS
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / PLEURA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
9.1%
3/33 • Number of events 3
|
0.00%
0/41
|
|
Cardiac disorders
PALPITATIONS
|
3.0%
1/33 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
6.1%
2/33 • Number of events 2
|
0.00%
0/41
|
|
Investigations
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
|
6.1%
2/33 • Number of events 2
|
9.8%
4/41 • Number of events 4
|
|
Blood and lymphatic system disorders
PLATELETS
|
15.2%
5/33 • Number of events 9
|
24.4%
10/41 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
9.1%
3/33 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
15.2%
5/33 • Number of events 10
|
14.6%
6/41 • Number of events 7
|
|
Cardiac disorders
PROLONGED QTC INTERVAL
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
9.1%
3/33 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
6.1%
2/33 • Number of events 3
|
19.5%
8/41 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION
|
0.00%
0/33
|
2.4%
1/41 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
RIGORS/CHILLS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Investigations
SODIUM, SERUM-HIGH (HYPERNATREMIA)
|
3.0%
1/33 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
24.2%
8/33 • Number of events 9
|
22.0%
9/41 • Number of events 11
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
General disorders
SWEATING (DIAPHORESIS)
|
6.1%
2/33 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
6.1%
2/33 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
3.0%
1/33 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
0.00%
0/33
|
4.9%
2/41 • Number of events 2
|
|
Ear and labyrinth disorders
TINNITUS
|
15.2%
5/33 • Number of events 5
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
ULCER, GI / STOMA
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
6.1%
2/33 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
3.0%
1/33 • Number of events 1
|
0.00%
0/41
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/33
|
2.4%
1/41 • Number of events 1
|
|
Eye disorders
VISION-BLURRED VISION
|
6.1%
2/33 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
0.00%
0/33
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
12.1%
4/33 • Number of events 5
|
14.6%
6/41 • Number of events 6
|
|
General disorders
WEIGHT GAIN
|
6.1%
2/33 • Number of events 2
|
0.00%
0/41
|
|
General disorders
WEIGHT LOSS
|
6.1%
2/33 • Number of events 3
|
22.0%
9/41 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place