Trial Outcomes & Findings for TK216 in Patients With Relapsed or Refractory Ewing Sarcoma (NCT NCT02657005)
NCT ID: NCT02657005
Last Updated: 2025-02-12
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions and pathologic lymph nodes; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, no new lesions, and no progression of non-target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
85 participants
Primary outcome timeframe
36 months
Results posted on
2025-02-12
Participant Flow
85 subjects were enrolled in this study across eight North American centers. The pathologic diagnoses were confirmed at each enrolling center. Most patients were heavily pretreated, with the median number of prior therapies being 3.0 (range, 1-10). The gender and ethnicity of the enrolled patients matched ES's prevalence in the U.S. population.
Once an appropriate patient has been identified, a 30-day screening period began and evaluated eligibility. The study was executed in several Parts: Part 1: Dose Escalation Segment (Cohorts 1-6) Part 2: Schedule Escalation Segment (Cohorts 7-9) Part 3: Expansion Segment (Cohort 10) Part 4: Dose and Schedule Evaluation Segment (Cohort 11) Note: For purposes of result summaries, Cohorts 1-8 pooled, Cohorts 9 \& 10 pooled, and Cohort 11 will be displayed.
Participant milestones
| Measure |
18 mg/m^2 (7 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
36 mg/m^2 (7 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
72 mg/m^2 (7 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
144 mg/m^2 (7 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (10 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (14 Days)
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
220 mg/m^2 (7 Days)
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
220 mg/m^2 (10 Days)
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
288 mg/m^2 (7 Days)
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
Expansion Cohort
Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle
|
175 mg/m^2 (28 Days)
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
4
|
4
|
3
|
3
|
7
|
44
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
4
|
4
|
3
|
3
|
7
|
44
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Baseline characteristics by cohort
| Measure |
18 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
36 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
72 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
144 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (10 Days)
n=4 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (14 Days)
n=4 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
220 mg/m^2 (7 Days)
n=3 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
220 mg/m^2 (10 Days)
n=3 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
288 mg/m^2 (7 Days)
n=7 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
Expansion Cohort
n=44 Participants
Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle
|
175 mg/m^2 (28 Days)
n=8 Participants
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
69 Participants
n=42 Participants
|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 28.7 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
30.0 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
25.5 years
STANDARD_DEVIATION 7.9 • n=8 Participants
|
24.7 years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
24.0 years
STANDARD_DEVIATION 10.0 • n=24 Participants
|
23.7 years
STANDARD_DEVIATION 6.3 • n=42 Participants
|
29.2 years
STANDARD_DEVIATION 14.6 • n=42 Participants
|
27.0 years
STANDARD_DEVIATION 10.0 • n=42 Participants
|
28.9 years
STANDARD_DEVIATION 13.1 • n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: All Patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions and pathologic lymph nodes; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, no new lesions, and no progression of non-target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
18 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
36 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
72 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
144 mg/m^2 (7 Days)
n=3 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (10 Days)
n=4 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
200 mg/m^2 (14 Days)
n=4 Participants
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216.
|
220 mg/m^2 (7 Days)
n=3 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
220 mg/m^2 (10 Days)
n=3 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
288 mg/m^2 (7 Days)
n=7 Participants
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
Expansion Cohort
n=44 Participants
Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle
|
175 mg/m^2 (28 Days)
n=8 Participants
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
18 mg/m^2 (7 Days)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
36 mg/m^2 (7 Days)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
72 mg/m^2 (7 Days)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
144 mg/m^2 (7 Days)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
200 mg/m^2 (10 Days)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
200 mg/m^2 (14 Days)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
220 mg/m^2 (7 Days)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
220 mg/m^2 (10 Days)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
288 mg/m^2 (7 Days)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 3 deaths
Expansion
Serious events: 21 serious events
Other events: 44 other events
Deaths: 26 deaths
175 mg/m^2
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
18 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
36 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
72 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
144 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
200 mg/m^2 (10 Days)
n=4 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
200 mg/m^2 (14 Days)
n=4 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
220 mg/m^2 (7 Days)
n=3 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
220 mg/m^2 (10 Days)
n=3 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
288 mg/m^2 (7 Days)
n=7 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
Expansion
n=44 participants at risk
Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle
|
175 mg/m^2
n=8 participants at risk
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Complication associated with device
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Number of events 3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Number of events 4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Aortobronchial fistula
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Nervous system disorders
Hypoglossal nerve paralysis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 5 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Number of events 2 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Number of events 4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Investigations
Blood Creatinine increased
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Number of events 1 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
Other adverse events
| Measure |
18 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
36 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
72 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
144 mg/m^2 (7 Days)
n=3 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
200 mg/m^2 (10 Days)
n=4 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
200 mg/m^2 (14 Days)
n=4 participants at risk
Dose Escalation Segment (Cohorts 1-6) was an open label, "3+3" patient enrollment scheme, sequential allocation, dose finding allocation of the sequential allocation of TK216 monotherapy. The length of TK216 infusion for all dose escalation cohorts was 7 days. A lower intermediate dose of 220mg/m2 /day for 7 days was determined to be the maximum tolerated dose (MTD) for the 7-day continuous infusion of TK216
|
220 mg/m^2 (7 Days)
n=3 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
220 mg/m^2 (10 Days)
n=3 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
288 mg/m^2 (7 Days)
n=7 participants at risk
Schedule Escalation Segment (Cohorts 7-9) was an open label, "3+3" patient enrollment scheme, sequential allocation of the increase in length of infusion of TK216 monotherapy. Following the first two cycles, vincristine could be added as tolerated up to 2mg on the first day of each cycle. The recommended Phase 2 dose (RP2D) was determined to be 200mg/m2 /day for 14 days followed by a 14-day recovery period, per 28-day cycle
|
Expansion
n=44 participants at risk
Expansion Segment (Cohort 10) where patients were treated with the schedule for RP2D of TK216 with vincristine 0.75 - 1.5 mg/m2 administered on the first day of each 28-day cycle
|
175 mg/m^2
n=8 participants at risk
Dose and Schedule Evaluation Segment (Cohort 11) where patients received a starting dose of 175mg/m2 /day of TK216 intravenously by continuous infusion for 28 days per cycle. If the patient's tumor response was determined by the Investigator as inadequate after at least one protocol-specified post-baseline assessment and they were not experiencing toxicities at this dose level, the Investigator could increase the dose to 200 mg/m2/day after discussion with the Sponsor. Vincristine (0.75 to 1.5 mg/m2 up to a maximum dose of 2 mg) could be administered in parallel with the TK216 infusion following progressive disease after TK216-01 monotherapy but only after consultation with the Sponsor
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
75.0%
3/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
3/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
57.1%
4/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
59.1%
26/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
75.0%
6/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
4/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
3/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
57.1%
4/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
22/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
62.5%
5/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
3/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
57.1%
4/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
40.9%
18/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
13.6%
6/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
4/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
3/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
40.9%
18/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
100.0%
3/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
34.1%
15/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
28.6%
2/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
36.4%
16/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
28.6%
2/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
20.5%
9/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
13.6%
6/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Investigations
Lymphocyte cunt decrease
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
75.0%
3/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
18.2%
8/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
2/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
13.6%
6/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
37.5%
3/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
13.6%
6/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
6.8%
3/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
2.3%
1/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
37.5%
3/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
6.8%
3/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
75.0%
3/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
28.6%
2/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
36.4%
16/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
37.5%
3/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
4.5%
2/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
75.0%
3/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
20.5%
9/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
6.8%
3/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
6.8%
3/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
66.7%
2/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
29.5%
13/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
42.9%
3/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
12.5%
1/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
50.0%
2/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
14.3%
1/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
11.4%
5/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
25.0%
1/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/4 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
33.3%
1/3 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/7 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
9.1%
4/44 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
0.00%
0/8 • Treatment emergent adverse events were collected from first treatment received through end of study for all patients. (i.e., 36 months)
Per clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place