Trial Outcomes & Findings for DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (NCT NCT03255083)
NCT ID: NCT03255083
Last Updated: 2022-01-19
Results Overview
A dose-limiting toxicity (DLT) was defined as any TEAE not attributable to disease or disease-related processes that occurred during the DLT-evaluation period (Cycle 0, Day 1 to Cycle 1, Day 21 of Dose Escalation) and was Grade 3 or above, according to NCI-CTCAE Version 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Cycle 0, Day 1 (7-day cycle) to Cycle 1, Day 21 of Dose Escalation (each cycle was 21 days)
Results posted on
2022-01-19
Participant Flow
A total of 13 participants who met all inclusion criteria and no exclusion criteria were enrolled from 10 April 2019 to 04 September 2020 in the study at 7 clinical sites in Taiwan.
In the dose escalation phase, the recommended dose for expansion of DS-1205c in combination with a fixed dose of osimertinib was assessed. The doses of DS-1205c selected for this study were based on nonclinical data and were expressed in doses of DS-1205a (free base).
Participant milestones
| Measure |
DS-1205c 200 mg + Osimertinib
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
DS-1205c 200 mg + Osimertinib
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Overall Study
Clinical progression
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Progressive disease by RECIST version 1.1
|
4
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
Baseline Characteristics
DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Age, Continuous
|
57.5 years
n=99 Participants
|
73.0 years
n=107 Participants
|
64.0 years
n=206 Participants
|
70 years
n=7 Participants
|
64.0 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 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
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
13 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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)
White
|
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)
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
|
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
|
|
Region of Enrollment
Taiwan
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
1 participants
n=7 Participants
|
13 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Cycle 0, Day 1 (7-day cycle) to Cycle 1, Day 21 of Dose Escalation (each cycle was 21 days)Population: Dose-limiting toxicities were assessed in the Safety Analysis Set.
A dose-limiting toxicity (DLT) was defined as any TEAE not attributable to disease or disease-related processes that occurred during the DLT-evaluation period (Cycle 0, Day 1 to Cycle 1, Day 21 of Dose Escalation) and was Grade 3 or above, according to NCI-CTCAE Version 5.0.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs) Following Administration With DS-1205c in Combination With Osimertinib
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening; Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 yearPopulation: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.
Treatment-emergent adverse events were defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiating the study drug until 30 days after last dose of the study drug.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Any TEAEs
|
6 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Upper respiratory tract infection
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Urinary tract infection
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Pneumonia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Anaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Insomnia
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Dizziness
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Headache
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Cough
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Dyspnoea
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Haemoptysis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Vomiting
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Diarrhoea
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Constipation
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Rash
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Fatigue
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Pyrexia
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Alanine aminotransferase increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Blood Creatinine Phosphokinase Increased
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Blood Creatinine Increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Ejection Fraction Decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Lipase Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Occurring in More Than 1 Participant Following Administration With DS-1205c in Combination With Osimertinib
Overdose
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 yearPopulation: Best overall response was assessed in the Full Analysis Set.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate is calculated as the number of participants with best objective response \[complete response (CR) or partial response (PR) determined by Investigator assessment based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1\], divided by the number of participants in the analysis population.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Stable disease (SD)
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Progressive disease (PD)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Not evaluable (NE)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
Overall response rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 yearPopulation: Disease control rate was assessed in the Full Analysis Set.
Disease control rate (DCR) is defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Disease Control Rate Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 yearPopulation: Progression-free survival was assessed in the Full Analysis Set.
Progression-free survival is defined as the time from the date of first dose to the earliest date of the first objective documentation of disease progression or death due to any cause. As per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Progression-free Survival Assessed by Investigator Following Administration of DS-1205c in Combination With Osimertinib
|
7.1 weeks
Interval 5.4 to 36.6
|
NA weeks
Interval 12.3 to
Lack of a median value is due to less than 50% of the participants experiencing the event. The estimated upper bound of 95% confidence interval is essentially infinity, therefore it is also N/A.
|
22.0 weeks
Interval 12.1 to 22.0
|
12.4 weeks
Not enough sample size to estimate a standard error for the median survival time so the 95% confidence interval bounds are N/A.
|
SECONDARY outcome
Timeframe: Screening; Cycle 0 (7-day cycle); Cycle 1 and beyond (21-day cycles), Every 6 weeks (± 7 days) in the first 24 weeks after Day 1 of Cycle 1, and every 12 weeks (± 7 days) thereafter; and end-of-treatment, 30 days after last dose, up to 1 yearPopulation: Overall survival was assessed in the Full Analysis Set.
Overall survival was defined as the time from the date of first dose to the date of death due to any cause.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Overall Survival in Participants Following Administration of DS-1205c in Combination With Osimertinib
|
46.9 weeks
Interval 34.0 to
The estimated upper bound of 95% confidence interval is essentially infinity, therefore it is N/A.
|
NA weeks
Interval 14.0 to
Lack of a median value is due to less than 50% of the participants experiencing the event. The estimated upper bound of 95% confidence interval is essentially infinity, therefore it is also N/A.
|
NA weeks
Interval 32.0 to
Lack of a median value is due to less than 50% of the participants experiencing the event. The estimated upper bound of 95% confidence interval is essentially infinity, therefore it is also N/A.
|
NA weeks
Not enough sample size to estimate a standard error for the median survival time so the median and 95% confidence interval bounds are both N/A.
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours of Cycle 0 (7-day cycle; DS-1205c alone), Day 1; Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0, Day 7 (DS-1205c alone); Predose, 1, 2, 4, 6, 8, 10, and 12 hours of Cycle 2 (21-day cycle), Day 1 (DS-1205c+osimertinib)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The maximum concentration (Cmax) of DS-1205c alone and in combination with osimertinib was assessed. Pharmacokinetic (PK) parameters for each participant were estimated using non-compartmental analysis. Descriptive statistics are provided for all plasma concentration data by analyte/dose/study day/time and for each PK parameter by analyte/dose/study day, as appropriate.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 1
|
292 ng/mL
Standard Deviation 94.8
|
413 ng/mL
Standard Deviation 94.0
|
499 ng/mL
Standard Deviation 222
|
703 ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Maximum Concentration (Cmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 7
|
561 ng/mL
Standard Deviation 191
|
827 ng/mL
Standard Deviation 299
|
1041 ng/mL
Standard Deviation 460
|
1070 ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Maximum Concentration (Cmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 2: Day 1
|
544 ng/mL
Standard Deviation 176
|
845 ng/mL
Standard Deviation 328
|
921 ng/mL
Standard Deviation 260
|
1150 ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours of Cycle 0 (7-day cycle; DS-1205c alone), Day 1; Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0, Day 7 (DS-1205c alone); Predose, 1, 2, 4, 6, 8, 10, and 12 hours of Cycle 2 (21-day cycle), Day 1 (DS-1205c+osimertinib)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The area under the plasma concentration curve from time 0 until last quantifiable time point (AUClast) and the area under the plasma concentration curve over a dosing interval (AUCtau) of DS-1205c alone and in combination with osimertinib were assessed. Pharmacokinetic (PK) parameters for each participant were estimated using non-compartmental analysis. Descriptive statistics are provided for all plasma concentration data by analyte/dose/study day/time and for each PK parameter by analyte/dose/study day, as appropriate.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUClast, Cycle 0: Day 1
|
1916 h*ng/mL
Standard Deviation 530
|
2493 h*ng/mL
Standard Deviation 277
|
2891 h*ng/mL
Standard Deviation 1398
|
5050 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUClast, Cycle 0: Day 7
|
4193 h*ng/mL
Standard Deviation 1514
|
5716 h*ng/mL
Standard Deviation 1931
|
7385 h*ng/mL
Standard Deviation 4562
|
8602 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUClast, Cycle 2: Day 1
|
4445 h*ng/mL
Standard Deviation 1389
|
6852 h*ng/mL
Standard Deviation 2716
|
7220 h*ng/mL
Standard Deviation 2629
|
9495 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUCtau, Cycle 0: Day 1
|
1975 h*ng/mL
Standard Deviation 563
|
2557 h*ng/mL
Standard Deviation 257
|
3002 h*ng/mL
Standard Deviation 1472
|
5255 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUCtau, Cycle 0: Day 7
|
4818 h*ng/mL
Standard Deviation 1772
|
6496 h*ng/mL
Standard Deviation 2208
|
6972 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
10300 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Area Under the Plasma Concentration Curve Following Administration of DS-1205c Alone and in Combination With Osimertinib
AUCtau, Cycle 2: Day 1
|
4596 h*ng/mL
Standard Deviation 1488
|
7117 h*ng/mL
Standard Deviation 2883
|
7640 h*ng/mL
Standard Deviation 2918
|
10000 h*ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours of Cycle 0 (7-day cycle; DS-1205c alone), Day 1; Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0, Day 7 (DS-1205c alone); Predose, 1, 2, 4, 6, 8, 10, and 12 hours of Cycle 2 (21-day cycle), Day 1 (DS-1205c+osimertinib)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The time to maximum concentration (Tmax) of DS-1205c alone and in combination with osimertinib was assessed. Pharmacokinetic (PK) parameters for each participant were estimated using non-compartmental analysis. Descriptive statistics are provided for all plasma concentration data by analyte/dose/study day/time and for each PK parameter by analyte/dose/study day, as appropriate.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 1
|
4.1 hours
Interval 2.0 to 6.0
|
4.0 hours
Interval 3.9 to 4.0
|
3.9 hours
Interval 2.0 to 4.0
|
6.2 hours
Interval 6.2 to 6.2
|
|
Time to Maximum Concentration (Tmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 7
|
4.0 hours
Interval 2.0 to 4.2
|
4.0 hours
Interval 2.1 to 4.0
|
4.0 hours
Interval 3.9 to 5.9
|
4.0 hours
Interval 4.0 to 4.0
|
|
Time to Maximum Concentration (Tmax) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 2: Day 1
|
4.1 hours
Interval 4.0 to 4.2
|
4.0 hours
Interval 2.0 to 4.1
|
2.1 hours
Interval 0.0 to 4.0
|
3.9 hours
Interval 3.9 to 3.9
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours of Cycle 0 (7-day cycle; DS-1205c alone), Day 1; Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0, Day 7 (DS-1205c alone); Predose, 1, 2, 4, 6, 8, 10, and 12 hours of Cycle 2 (21-day cycle), Day 1 (DS-1205c+osimertinib)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The trough plasma concentration (Ctrough) of DS-1205c alone and in combination with osimertinib was assessed. Pharmacokinetic (PK) parameters for each participant were estimated using non-compartmental analysis. Descriptive statistics are provided for all plasma concentration data by analyte/dose/study day/time and for each PK parameter by analyte/dose/study day, as appropriate.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 7
|
376 ng/mL
Standard Deviation 143
|
460 ng/mL
Standard Deviation 219
|
688 ng/mL
Standard Deviation 631
|
816 ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Trough Plasma Concentration (Ctrough) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 2: Day 1
|
359 ng/mL
Standard Deviation 137
|
576 ng/mL
Standard Deviation 275
|
722 ng/mL
Standard Deviation 406
|
903 ng/mL
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours of Cycle 0 (7-day cycle; DS-1205c alone), Day 1; Predose, 1, 2, 4, 6, 8, and 10 hours of Cycle 0, Day 7 (DS-1205c alone); Predose, 1, 2, 4, 6, 8, 10, and 12 hours of Cycle 2 (21-day cycle), Day 1 (DS-1205c+osimertinib)Population: The pharmacokinetic parameter of terminal half-life (t1/2) was assessed in the Pharmacokinetic Analysis Set, except for 1 patient (Cohort 1) who did not have an available sample.
The terminal half-life (t1/2) of DS-1205c alone and in combination with osimertinib was assessed. Pharmacokinetic (PK) parameters for each participant were estimated using non-compartmental analysis. Descriptive statistics are provided for all plasma concentration data by analyte/dose/study day/time and for each PK parameter by analyte/dose/study day, as appropriate.
Outcome measures
| Measure |
DS-1205c 200 mg + Osimertinib
n=5 Participants
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 Participants
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 Participants
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 1
|
6.98 hours
Standard Deviation 1.89
|
5.3 hours
Standard Deviation 1.0
|
4.7 hours
Standard Deviation 0.6
|
3.3 hours
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
|
Terminal Half-life (t1/2) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 0: Day 7
|
11.6 hours
Standard Deviation 6.7
|
7.1 hours
Standard Deviation 1.0
|
6.9 hours
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
—
|
|
Terminal Half-life (t1/2) Following Administration of DS-1205c Alone and in Combination With Osimertinib
Cycle 2: Day 1
|
9.8 hours
Standard Deviation 3.3
|
7.9 hours
Standard Deviation 0.8
|
7.0 hours
Standard Deviation 1.3
|
11.7 hours
Standard Deviation NA
Due to small sample size, standard deviation could not be calculated.
|
Adverse Events
DS-1205c 200 mg + Osimertinib
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
DS-1205c 400 mg + Osimertinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DS-1205c 800 mg + Osimertinib
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
DS-1205c 1200 mg + Osimertinib
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 participants at risk
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 participants at risk
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 participants at risk
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 participants at risk
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Meninges
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
Other adverse events
| Measure |
DS-1205c 200 mg + Osimertinib
n=6 participants at risk
Participants who received DS-1205c 200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 400 mg + Osimertinib
n=3 participants at risk
Participants who received DS-1205c 400 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 400 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 800 mg + Osimertinib
n=3 participants at risk
Participants who received DS-1205c 800 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 800 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
DS-1205c 1200 mg + Osimertinib
n=1 participants at risk
Participants who received DS-1205c 1200 mg twice daily (BID) at Cycle 0 monotherapy of a 7-day cycle and DS-1205c 1200 mg BID in combination with 80 mg oral dose of osimertinib daily (QD) at Cycle 1 and beyond of a 21-day cycle.
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemopytsis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Breath sounds abnormal
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Eye disorders
Conjunctivitis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Eye disorders
Cornea verticillata
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Haematuria
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Paronychia
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
100.0%
1/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
0.00%
0/1 • Treatment-emergent adverse events (TEAEs) were collected at Screening, Cycle 0 (7-day cycle), Days -1, 1, 2, 4, 6, and 7; Cycle 1 (21-day cycle), Days 4, 8, and 15; Cycle 2 (21-day cycle), Days 1, 2, and 8; Cycle 3 and beyond (21-day cycles), Day 1; and end-of-treatment, 30 days after last dose, up to 1 year.
A TEAE is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity after the initiation of the study drug until 30 days after last dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place