Trial Outcomes & Findings for Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma (NCT NCT04292743)
NCT ID: NCT04292743
Last Updated: 2025-06-11
Results Overview
The number (percentage) of all subjects who experience Grad 3 or 4 treatment emergent adverse events (AEs), serious adverse events (SAEs), or abnormal laboratory results according to NCI CTCAE Version 5.0, that occur after Cycle 1, Day 1 will be reported until end of treatment visit.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
1 year
Results posted on
2025-06-11
Participant Flow
Participant milestones
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level -1 (50 Units/kg) Plus FOLFIRINOX
Eryaspase 50 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level -2 (25 Units/kg) Plus FOLFIRINOX
Eryaspase 25 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
16
|
0
|
0
|
Reasons for withdrawal
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level -1 (50 Units/kg) Plus FOLFIRINOX
Eryaspase 50 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level -2 (25 Units/kg) Plus FOLFIRINOX
Eryaspase 25 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion).
intravenous administration of mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Progression of Disease
|
2
|
5
|
0
|
0
|
|
Overall Study
No Treatment per protocol
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 Participants
Eryaspase (75 Units/kg) will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 Participants
Eryaspase (100 Units/kg) will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe number (percentage) of all subjects who experience Grad 3 or 4 treatment emergent adverse events (AEs), serious adverse events (SAEs), or abnormal laboratory results according to NCI CTCAE Version 5.0, that occur after Cycle 1, Day 1 will be reported until end of treatment visit.
Outcome measures
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 Participants
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 Participants
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion) in dose escalating/reduction depending on the cohort the patient is assigned to
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Incidence of Grade 3 or 4 Adverse Events
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with a complete or partial response from treatment as assessed by CT scan per RECIST 1.1 criteria.
Outcome measures
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 Participants
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 Participants
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion) in dose escalating/reduction depending on the cohort the patient is assigned to
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Objective Response Rate by RECIST 1.1
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTime in months from start of treatment to disease progression, death, or completion of study which ever occurred first.
Outcome measures
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 Participants
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 Participants
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion) in dose escalating/reduction depending on the cohort the patient is assigned to
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.6 months
Interval 1.8 to 28.3
|
6.4 months
Interval 0.4 to 34.7
|
SECONDARY outcome
Timeframe: 3 yearsThe length of time from treatment initiation until death from any cause or off study date, whichever occurs first.
Outcome measures
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 Participants
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 Participants
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion) in dose escalating/reduction depending on the cohort the patient is assigned to
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Overall Survival (OS)
|
10.2 months
Interval 8.7 to 28.3
|
8.6 months
Interval 0.4 to 34.7
|
Adverse Events
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
Serious events: 2 serious events
Other events: 14 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 participants at risk
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 participants at risk
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
Other adverse events
| Measure |
Eryaspase Dose Level 0 (75 Units/kg) Plus FOLFIRINOX
n=3 participants at risk
Eryaspase 75 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
Eryaspase Dose Level 1 (100 Units/kg) Plus FOLFIRINOX
n=16 participants at risk
Eryaspase 100 Units/kg will be administered on day 1 and 15 of a 4 week cycle (intravenous infusion)
mFOLFIRINOX dosing will include 5-fluorouracil 2400 mg/m² over 46 hours, oxaliplatin 85 mg/m², Irinotecan 150 mg/m² (intravenous infusion) on Day 1 and 15 of the 4 weeks cycle for a maximum of 12 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
68.8%
11/16 • Number of events 27 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Eye disorders
Watering eyes
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 9 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Belching
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
43.8%
7/16 • Number of events 10 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
50.0%
8/16 • Number of events 21 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
50.0%
8/16 • Number of events 13 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
37.5%
6/16 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 9 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
75.0%
12/16 • Number of events 35 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Generalized edema
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Infections and infestations
Gum infection
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Infections and infestations
Thrush
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
50.0%
8/16 • Number of events 9 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
3/3 • Number of events 5 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
50.0%
8/16 • Number of events 10 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
37.5%
6/16 • Number of events 9 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
100.0%
3/3 • Number of events 5 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
GGT increased
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
31.2%
5/16 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 5 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
50.0%
8/16 • Number of events 13 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Serum amylase increased
|
33.3%
1/3 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 7 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
43.8%
7/16 • Number of events 9 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 7 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 6 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 5 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
37.5%
6/16 • Number of events 8 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 7 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
0.00%
0/16 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 5 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
3/3 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
62.5%
10/16 • Number of events 19 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
12.5%
2/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
66.7%
2/3 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
6.2%
1/16 • Number of events 1 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
18.8%
3/16 • Number of events 3 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
25.0%
4/16 • Number of events 4 • Adverse Events were assessed for 1 year (from Cycle 1, Day 1 will be reported until end of treatment visit.). All cause mortality was assessed up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place