Trial Outcomes & Findings for Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors (NCT NCT00607048)
NCT ID: NCT00607048
Last Updated: 2017-03-27
Results Overview
Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC \<1000/mm\^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm\^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr \<1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC \<1000 cells/mm\^3 or platelets \<80000 cells/mm\^3, or non-hematologic toxicity ≥Gr 2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21
Results posted on
2017-03-27
Participant Flow
16 participants were screened, enrolled, and received at least 1 dose of study treatment in Schedule A. 18 participants were screened and enrolled in Schedule B; however, 2 participants discontinued before assignment to study treatment; 16 participants received at least 1 dose of study treatment in Schedule B.
Participant milestones
| Measure |
Schedule A - CP-870893 0.1 mg/kg
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
7
|
3
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
2
|
3
|
0
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
Schedule A - CP-870893 0.1 mg/kg
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
4
|
0
|
|
Overall Study
Global deterioration of health
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Objective disease progression - relapse
|
1
|
2
|
4
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Schedule A - CP-870893
n=16 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893
n=16 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
56.4 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21Population: Safety population: all participants who received at least 1 dose of study treatment.
Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC \<1000/mm\^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm\^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr \<1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC \<1000 cells/mm\^3 or platelets \<80000 cells/mm\^3, or non-hematologic toxicity ≥Gr 2.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months)Population: Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893.
Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL).
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
0.97 mcg/mL
Standard Deviation 0.43
|
1.51 mcg/mL
Standard Deviation 0.60
|
1.36 mcg/mL
Standard Deviation 0.68
|
0.61 mcg/mL
Standard Deviation NA
Standard deviation not calculated for N \<3.
|
1.97 mcg/mL
Standard Deviation 0.99
|
1.06 mcg/mL
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months)Population: Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893.
Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng\*mcg/mL).
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
3.37 hr*mcg/mL
Standard Deviation 1.2
|
10.4 hr*mcg/mL
Standard Deviation 9.3
|
7.5 hr*mcg/mL
Standard Deviation 8.7
|
1.35 hr*mcg/mL
Standard Deviation NA
Standard deviation not calculated for N \<3.
|
13.0 hr*mcg/mL
Standard Deviation 10.3
|
5.71 hr*mcg/mL
Standard Deviation 5.36
|
SECONDARY outcome
Timeframe: Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months)Population: All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response.
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=16 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=16 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response
|
2 participants
|
3 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdosePopulation: Pharmacokinetic data analysis set.
Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)
CYTO0
|
10.57 picograms per milliliter (pg/mL)
Standard Deviation 5.8106
|
12.10 picograms per milliliter (pg/mL)
Standard Deviation 9.5896
|
14.52 picograms per milliliter (pg/mL)
Standard Deviation 14.674
|
3.547 picograms per milliliter (pg/mL)
Standard Deviation 0.7390
|
41.34 picograms per milliliter (pg/mL)
Standard Deviation 72.595
|
8.040 picograms per milliliter (pg/mL)
Standard Deviation 6.6632
|
|
Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)
CYTOMAX
|
120.67 picograms per milliliter (pg/mL)
Standard Deviation 92.5545
|
275.48 picograms per milliliter (pg/mL)
Standard Deviation 427.617
|
371.22 picograms per milliliter (pg/mL)
Standard Deviation 379.799
|
113.45 picograms per milliliter (pg/mL)
Standard Deviation 42.1629
|
339.00 picograms per milliliter (pg/mL)
Standard Deviation 185.140
|
679.40 picograms per milliliter (pg/mL)
Standard Deviation 856.849
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdosePopulation: Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ).
Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX
CYTO0
|
15.60 pg/mL
Standard Deviation 0.0000
|
15.60 pg/mL
Standard Deviation 0.0000
|
15.60 pg/mL
Standard Deviation 0.0000
|
15.60 pg/mL
Standard Deviation 0.0000
|
15.60 pg/mL
Standard Deviation 0.0000
|
15.60 pg/mL
Standard Deviation 0.0000
|
|
Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX
CYTOMAX
|
155.73 pg/mL
Standard Deviation 151.527
|
108.90 pg/mL
Standard Deviation 148.896
|
113.11 pg/mL
Standard Deviation 75.4270
|
212.73 pg/mL
Standard Deviation 166.857
|
161.90 pg/mL
Standard Deviation 196.651
|
675.34 pg/mL
Standard Deviation 1263.56
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean.
Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)
PD0
|
5.81 percentage of cells
Standard Deviation 1.4284
|
9.12 percentage of cells
Standard Deviation 5.2037
|
11.3257 percentage of cells
Standard Deviation 6.1987
|
13.5233 percentage of cells
Standard Deviation 13.8885
|
9.42 percentage of cells
Standard Deviation 5.1037
|
6.5514 percentage of cells
Standard Deviation 3.3797
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)
PDMAX
|
4.99 percentage of cells
Standard Deviation 0.9758
|
7.3017 percentage of cells
Standard Deviation 5.1317
|
9.4614 percentage of cells
Standard Deviation 5.0745
|
6.7133 percentage of cells
Standard Deviation 3.8467
|
7.7783 percentage of cells
Standard Deviation 4.4316
|
4.6786 percentage of cells
Standard Deviation 2.9114
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set; N=Number of participants contributing to the mean.
Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax
PDMAX
|
6.615 percentage of cells
Standard Deviation 8.2237
|
11.7883 percentage of cells
Standard Deviation 17.8460
|
13.6929 percentage of cells
Standard Deviation 27.7995
|
0.65 percentage of cells
Standard Deviation 0.6497
|
18.9517 percentage of cells
Standard Deviation 38.0439
|
12.6514 percentage of cells
Standard Deviation 26.8913
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax
PD0
|
99.265 percentage of cells
Standard Deviation 0.7566
|
99.8267 percentage of cells
Standard Deviation 0.2447
|
99.0043 percentage of cells
Standard Deviation 1.4442
|
99.9833 percentage of cells
Standard Deviation 0.0289
|
99.6533 percentage of cells
Standard Deviation 0.4772
|
88.07 percentage of cells
Standard Deviation 28.0802
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set; N=Number of participants contributing to the mean.
Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax
PD0
|
71.155 percentage of cells
Standard Deviation 16.3554
|
86.2267 percentage of cells
Standard Deviation 8.7526
|
80.4843 percentage of cells
Standard Deviation 14.5377
|
90.2333 percentage of cells
Standard Deviation 5.0997
|
85.26 percentage of cells
Standard Deviation 5.2701
|
83.0943 percentage of cells
Standard Deviation 8.7534
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax
PDMAX
|
22.155 percentage of cells
Standard Deviation 14.2765
|
36.735 percentage of cells
Standard Deviation 30.9453
|
20.0857 percentage of cells
Standard Deviation 8.1089
|
7.58 percentage of cells
Standard Deviation 4.8650
|
22.3183 percentage of cells
Standard Deviation 17.2221
|
33.3057 percentage of cells
Standard Deviation 24.0570
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set; N=Number of participants contributing to the mean.
Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax
PDMAX
|
28.505 percentage of cells
Standard Deviation 32.0532
|
25.85 percentage of cells
Standard Deviation 25.9993
|
23.5229 percentage of cells
Standard Deviation 15.4014
|
1.7 percentage of cells
Standard Deviation 1.5156
|
33.2017 percentage of cells
Standard Deviation 33.3072
|
21.1886 percentage of cells
Standard Deviation 33.3022
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax
PD0
|
95.735 percentage of cells
Standard Deviation 5.8902
|
94.7667 percentage of cells
Standard Deviation 9.0938
|
97.9486 percentage of cells
Standard Deviation 0.8686
|
99.6367 percentage of cells
Standard Deviation 0.3465
|
96.4867 percentage of cells
Standard Deviation 3.7710
|
94.5571 percentage of cells
Standard Deviation 2.9589
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set; N=Number of participants contributing to the mean.
Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax
PD0
|
3.91 percentage of cells
Standard Deviation 0.4384
|
5.8167 percentage of cells
Standard Deviation 3.4037
|
18.7629 percentage of cells
Standard Deviation 8.2298
|
5.5367 percentage of cells
Standard Deviation 4.4152
|
9.23 percentage of cells
Standard Deviation 5.1565
|
16.7186 percentage of cells
Standard Deviation 5.4602
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax
PDMAX
|
12.795 percentage of cells
Standard Deviation 3.0618
|
26.275 percentage of cells
Standard Deviation 23.1242
|
11.9443 percentage of cells
Standard Deviation 10.3140
|
18.04 percentage of cells
Standard Deviation 19.9811
|
28.0917 percentage of cells
Standard Deviation 16.5569
|
34.3943 percentage of cells
Standard Deviation 18.5593
|
SECONDARY outcome
Timeframe: Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdosePopulation: Biomarker data analysis set; N=Number of participants contributing to the mean.
Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.
Outcome measures
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=2 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 Participants
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax
PD0
|
98.24 percentage of cells
Standard Deviation 2.1355
|
98.325 percentage of cells
Standard Deviation 1.9341
|
99.0986 percentage of cells
Standard Deviation 0.4929
|
99.7833 percentage of cells
Standard Deviation 0.2021
|
97.4 percentage of cells
Standard Deviation 3.4616
|
98.5643 percentage of cells
Standard Deviation 1.8466
|
|
Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax
PDMAX
|
33.88 percentage of cells
Standard Deviation 38.3818
|
27.4983 percentage of cells
Standard Deviation 24.3301
|
21.7857 percentage of cells
Standard Deviation 12.1245
|
2.7833 percentage of cells
Standard Deviation 2.5010
|
15.1783 percentage of cells
Standard Deviation 20.5400
|
27.0986 percentage of cells
Standard Deviation 33.2939
|
SECONDARY outcome
Timeframe: Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months)Population: Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32).
HAHA assessed as an indicator of immunogenicity to CP-870893.
Outcome measures
Outcome data not reported
Adverse Events
Schedule A - CP-870893 0.1 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Schedule B - CP-870893 0.1 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Optic nerve infarction
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Schedule A - CP-870893 0.1 mg/kg
n=3 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
Schedule B - CP-870893 0.1 mg/kg
n=3 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)
n=6 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).
|
Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)
n=7 participants at risk
Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.
If 0 out of 3 or \<2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
71.4%
5/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
100.0%
3/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
83.3%
5/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
85.7%
6/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
4/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
85.7%
6/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Cytokine release syndrome
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
85.7%
6/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
85.7%
6/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
66.7%
2/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 43 days after last dose of study treatment.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER