Trial Outcomes & Findings for SGI-110 in Combination With Carboplatin in Ovarian Cancer (NCT NCT01696032)
NCT ID: NCT01696032
Last Updated: 2024-08-27
Results Overview
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2024-08-27
Participant Flow
A total of 124 participants were enrolled in the study and 120 were treated at 20 study centers, with 12 in the United States, 5 in the United Kingdom, and 3 in Canada. The enrollment period was 10 December 2012 (first participant dosed) to 12 May 2014 (last participant first dose).
Participant milestones
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); pegylated liposomal doxorubicin (PLD) (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion). Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
51
|
49
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
27
|
|
Overall Study
NOT COMPLETED
|
14
|
6
|
51
|
22
|
Reasons for withdrawal
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); pegylated liposomal doxorubicin (PLD) (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion). Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
|
Overall Study
Death
|
14
|
4
|
43
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Database lock
|
0
|
1
|
7
|
2
|
Baseline Characteristics
SGI-110 in Combination With Carboplatin in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion. Participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.99 Years
STANDARD_DEVIATION 9.47 • n=99 Participants
|
56.79 Years
STANDARD_DEVIATION 13.20 • n=107 Participants
|
61.96 Years
STANDARD_DEVIATION 9.17 • n=206 Participants
|
62.09 Years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
61.29 Years
STANDARD_DEVIATION 9.62 • n=31 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
120 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
114 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
100 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Safety data set includes data from all participants who received any amount of study drug, including any component of a multi-dose study treatment regimen.
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Stage 1: Dose Limiting Toxicities
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment \[guadecitabine+carboplatin (G+C) or treatment choice (TC)\] until disease progression or unacceptable treatment-related toxicity occurred.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=49 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Stage 2: Progression Free Survival
|
114 Days
Interval 63.0 to 169.0
|
64 Days
Interval 52.0 to 105.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Objective Response Rate
|
21 Percent
Interval 4.7 to 50.8
|
0 Percent
Interval 0.0 to 45.9
|
16 Percent
Interval 7.0 to 28.6
|
8 Percent
Interval 2.3 to 19.6
|
4 Percent
Interval 0.1 to 19.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Progression Free Survival at 6 Months
|
0.36 Percent of participants
Interval 0.13 to 0.59
|
0.33 Percent of participants
Interval 0.05 to 0.68
|
0.37 Percent of participants
Interval 0.24 to 0.5
|
0.11 Percent of participants
Interval 0.04 to 0.22
|
0.19 Percent of participants
Interval 0.07 to 0.35
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate
|
43 Percent of participants
Interval 17.7 to 71.1
|
50 Percent of participants
Interval 11.8 to 88.2
|
41 Percent of participants
Interval 27.6 to 55.8
|
29 Percent of participants
Interval 16.6 to 43.3
|
19 Percent of participants
Interval 6.3 to 38.1
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Percentage of participants with CA-125 reduction by ≥ 50% from baseline
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
CA-125 Levels
|
27 Percent of participants
Interval 6.0 to 61.0
|
50 Percent of participants
Interval 6.8 to 93.2
|
36 Percent of participants
Interval 21.6 to 52.0
|
32 Percent of participants
Interval 18.1 to 48.1
|
29 Percent of participants
Interval 11.3 to 52.2
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=6 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=3 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=21 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=14 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=5 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Duration of Response
|
225 Days
Interval 42.0 to 294.0
|
195 Days
Interval 114.0 to
Not estimable with current data
|
186 Days
Interval 147.0 to 241.0
|
173 Days
Interval 121.0 to 267.0
|
182 Days
Interval 147.0 to 233.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Efficacy data set included all participants who received any amount of study drug.
Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 Participants
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 Participants
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Overall Survival
|
341 Days
Interval 100.0 to 567.0
|
195 Days
Interval 25.0 to
Not estimable with current data
|
331 Days
Interval 231.0 to 415.0
|
221 Days
Interval 145.0 to 372.0
|
279 Days
Interval 161.0 to 413.0
|
SECONDARY outcome
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)Population: The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.
Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=5 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Stage 1: Pharmacokinetic Parameter Cmax
Guadecitabine
|
96.2 ng/mL
Standard Deviation 78.3
|
109 ng/mL
Standard Deviation 70.8
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter Cmax
Carboplatin
|
19600 ng/mL
Standard Deviation 5650
|
21900 ng/mL
Standard Deviation 13800
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter Cmax
Decitabine
|
22.6 ng/mL
Standard Deviation 13.3
|
26.3 ng/mL
Standard Deviation 14.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)Population: The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.
Time to last measurable concentration for guadecitabine, decitabine and carboplatin
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=5 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Stage 1: Pharmacokinetic Parameter Tmax
Guadecitabine
|
1.42 Hours
Interval 0.25 to 6.0
|
1.98 Hours
Interval 1.5 to 7.25
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter Tmax
Decitabine
|
1.98 Hours
Interval 1.0 to 6.0
|
3.95 Hours
Interval 1.67 to 7.25
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter Tmax
Carboplatin
|
1.03 Hours
Interval 0.48 to 1.2
|
1.05 Hours
Interval 0.48 to 1.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)Population: The pharmacokinetic (PK) population included participants for which sufficient data were available to calculate PK parameters.
Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin
Outcome measures
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=13 Participants
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=4 Participants
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Stage 1: Pharmacokinetic Parameter AUC0-8
Guadecitabine
|
239 Hours*ng/mL
Standard Deviation 136
|
416 Hours*ng/mL
Standard Deviation 217
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter AUC0-8
Decitabine
|
71.1 Hours*ng/mL
Standard Deviation 26.6
|
129 Hours*ng/mL
Standard Deviation 17.9
|
—
|
—
|
—
|
|
Stage 1: Pharmacokinetic Parameter AUC0-8
Carboplatin
|
51200 Hours*ng/mL
Standard Deviation 12100
|
41900 Hours*ng/mL
Standard Deviation 31700
|
—
|
—
|
—
|
Adverse Events
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
Serious events: 8 serious events
Other events: 14 other events
Deaths: 14 deaths
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
Serious events: 26 serious events
Other events: 50 other events
Deaths: 43 deaths
Stage 2: Treatment Choice
Serious events: 24 serious events
Other events: 49 other events
Deaths: 18 deaths
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
Serious events: 12 serious events
Other events: 27 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 participants at risk
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 participants at risk
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 participants at risk
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 participants at risk
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 participants at risk
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Elective procedure
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
International normalized ratio increased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Transaminases increased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Seizure
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Peripheral neuropathy sensory
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
15.7%
8/51 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
18.5%
5/27 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
10.2%
5/49 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal abscess
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infections
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Postoperative fever
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
Other adverse events
| Measure |
Stage 1: Guadecitabine+Carboplatin 30 mg/m2
n=14 participants at risk
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 1: Guadecitabine+Carboplatin 45 mg/m2
n=6 participants at risk
Guadecitabine 45 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles. Due to dose limiting toxicities, the guadecitabine dose for this group was reduced from 45 mg/m2 to 30 mg/m2 after Cycle 1 for 4 of 6 participants and the carboplatin dose was reduced for 2 of 6 participants.
|
Stage 2: Guadecitabine+Carboplatin 30 mg/m2
n=51 participants at risk
Guadecitabine 30 mg/m2 on Days 1-5 and carboplatin AUC 4 on Day 8 of 28-day treatment cycles.
|
Stage 2: Treatment Choice
n=49 participants at risk
Treatment was selected at the investigator's discretion and administered based on recommended dosing for topotecan (3.5-4.0 mg/m2/wk administered on Days 1, 8, and 15 via IV infusion); PLD (40-50 mg/m2 administered on Day 1 via IV infusion), paclitaxel (60-80 mg/m2/wk administered on Days 1, 8, 15, and 22 via IV infusion), or gemcitabine (800-1000 mg/m2 administered on Days 1, 8, and 15 via IV infusion).
|
Stage 2: Crossover Treatment Choice to Guadecitabine+Carboplatin 30 mg/m2
n=27 participants at risk
Crossover from treatment choice to the guadecitabine+carboplatin combination treatment arm was permitted for participants after evidence of disease progression.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
26.5%
13/49 • Number of events 13 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
10.2%
5/49 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Perineal pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
13.7%
7/51 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Lymphedema
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Fatigue
|
64.3%
9/14 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
64.7%
33/51 • Number of events 33 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
53.1%
26/49 • Number of events 26 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
51.9%
14/27 • Number of events 14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Injection site reaction
|
57.1%
8/14 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
45.1%
23/51 • Number of events 23 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
9/27 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
15.7%
8/51 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Peripheral edema
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
28.6%
14/49 • Number of events 14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Adverse drug reaction
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
14.8%
4/27 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Hernia pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Early satiety
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Injection site pain
|
28.6%
4/14 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
General disorders
Mass
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.8%
6/51 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
10.2%
5/49 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Anion gap increased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Aspartate aminotransferase
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Bilirubin urine present
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood albumin decreased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood chloride decreased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Carbon dioxide decreased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Protein urine present
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Weight increased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Specific gravity urine increased
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Urine ketone body present
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Urine leukocyte esterase positive
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood phosphorous decreased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Protein total decreased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
13.7%
7/51 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Investigations
International normalized ratio increased
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
7/14 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
83.3%
5/6 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
70.6%
36/51 • Number of events 36 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
32.7%
16/49 • Number of events 16 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
18/27 • Number of events 18 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.7%
5/14 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
31.4%
16/51 • Number of events 16 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
22.4%
11/49 • Number of events 11 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
44.4%
12/27 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
7/14 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
31.4%
16/51 • Number of events 16 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
51.0%
25/49 • Number of events 25 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
29.6%
8/27 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
100.0%
6/6 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
23.5%
12/51 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
24.5%
12/49 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
37.0%
10/27 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
27.5%
14/51 • Number of events 14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
30.6%
15/49 • Number of events 15 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
18.5%
5/27 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
13.7%
7/51 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.3%
8/49 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
14.8%
4/27 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
17.6%
9/51 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
10.2%
5/49 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Parasthesia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
10/14 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
74.5%
38/51 • Number of events 38 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
57.1%
28/49 • Number of events 28 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
44.4%
12/27 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
6/14 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
62.7%
32/51 • Number of events 32 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
30.6%
15/49 • Number of events 15 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
37.0%
10/27 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
35.7%
5/14 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
43.1%
22/51 • Number of events 22 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
34.7%
17/49 • Number of events 17 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
37.0%
10/27 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
4/14 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
41.2%
21/51 • Number of events 21 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
34.7%
17/49 • Number of events 17 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
29.6%
8/27 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
4/14 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
41.2%
21/51 • Number of events 21 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
22.4%
11/49 • Number of events 11 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
9/27 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
21.6%
11/51 • Number of events 11 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
24.5%
12/49 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
19.6%
10/51 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
24.5%
12/49 • Number of events 12 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
14.8%
4/27 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.8%
6/51 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
20.4%
10/49 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
15.7%
8/51 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
10.2%
5/49 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Hematuria
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
13.7%
7/51 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.8%
6/51 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
14.3%
7/49 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
13.7%
7/51 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
17.6%
9/51 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.3%
8/49 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
18.5%
5/27 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
21.6%
11/51 • Number of events 11 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
19.6%
10/51 • Number of events 10 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.3%
8/49 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.8%
6/51 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
9.8%
5/51 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
29.4%
15/51 • Number of events 15 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.3%
8/49 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
9/27 • Number of events 9 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
6/14 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
27.5%
14/51 • Number of events 14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
26.5%
13/49 • Number of events 13 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
22.2%
6/27 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.8%
6/51 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.3%
8/49 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
14.3%
7/49 • Number of events 7 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.8%
4/51 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
12.2%
6/49 • Number of events 6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
18.5%
5/27 • Number of events 5 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/49 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
6.1%
3/49 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.9%
2/51 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Bacteriuria
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Breast cellulitis
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Localized infection
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
7.4%
2/27 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
5.9%
3/51 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Rocky mountain spotted fever
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
15.7%
8/51 • Number of events 8 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
8.2%
4/49 • Number of events 4 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
11.1%
3/27 • Number of events 3 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Vaginitis bacterial
|
7.1%
1/14 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
3.7%
1/27 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Impetigo
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/51 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/49 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
2.0%
1/51 • Number of events 1 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
4.1%
2/49 • Number of events 2 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
0.00%
0/27 • Approximately 4 years
Treatment-emergent adverse events (TEAEs) were defined as events that first occurred or worsened after the first dose of study drug given on Cycle 1 Day 1 until 30 days after the last dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place