Trial Outcomes & Findings for S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer (NCT NCT01959139)
NCT ID: NCT01959139
Last Updated: 2024-02-09
Results Overview
Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting \> 7 days; grade ≥ 3 febrile neutropenia; grade ≥ 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by \> 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
126 participants
Primary outcome timeframe
2 cycles of 14 days
Results posted on
2024-02-09
Participant Flow
126 participants were enrolled to this study, however, 1 withdrew consent and 3 were ineligible.
Participant milestones
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX + PEGPH20
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Phase I: Cohort 1
STARTED
|
5
|
0
|
0
|
0
|
|
Phase I: Cohort 1
COMPLETED
|
5
|
0
|
0
|
0
|
|
Phase I: Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase I: Cohort 2
STARTED
|
0
|
6
|
0
|
0
|
|
Phase I: Cohort 2
COMPLETED
|
0
|
6
|
0
|
0
|
|
Phase I: Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
56
|
55
|
|
Phase II
Assessed for AEs
|
0
|
0
|
54
|
51
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
56
|
55
|
Reasons for withdrawal
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX + PEGPH20
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Phase II
Disease progression
|
0
|
0
|
26
|
34
|
|
Phase II
Adverse Event
|
0
|
0
|
10
|
11
|
|
Phase II
Patient Refusal
|
0
|
0
|
5
|
4
|
|
Phase II
Death
|
0
|
0
|
3
|
1
|
|
Phase II
Other/Unknown
|
0
|
0
|
8
|
5
|
|
Phase II
On treatment
|
0
|
0
|
4
|
0
|
Baseline Characteristics
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=5 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
n=6 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX
n=56 Participants
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: mFOLFIRINOX + PEGPH20
n=55 Participants
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
n=99 Participants
|
60.2 years
n=107 Participants
|
60.5 years
n=206 Participants
|
63.9 years
n=7 Participants
|
62.2 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
12 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
96 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Zubrod performance status
0
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=31 Participants
|
|
Zubrod performance status
1
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Primary site
Head of pancreas
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Primary site
Body of pancreas
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Primary site
Tail of pancreas
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Primary site
Pancreas, NOS
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Sites of involvement
Primary tumor/pancreas
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
108 Participants
n=31 Participants
|
|
Sites of involvement
Regional lymph nodes
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Sites of involvement
Distant lymph nodes
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sites of involvement
Lung
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Sites of involvement
Liver
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=31 Participants
|
|
Sites of involvement
Peritoneum
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Sites of involvement
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Serum cancer antigen (CA) 19-9
< 37
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Serum cancer antigen (CA) 19-9
>= 37
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=31 Participants
|
|
Prior treatment for pancreatic cancer
Chemotherapy
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Prior treatment for pancreatic cancer
Surgery
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 cycles of 14 daysPopulation: All analyzable patients who experienced a dose limiting toxicity attributable to PEGPH20 and/or mFOLFIRINOX in the first cycle
Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting \> 7 days; grade ≥ 3 febrile neutropenia; grade ≥ 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by \> 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached.
Outcome measures
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=5 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1
n=6 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
All Phase 1 Participants
n=11 Participants
Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
|
Phase II: PEGPH20 + mFOLFIRINOX
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX
|
0 ug/kg
|
3 ug/kg
|
3 ug/kg
|
—
|
PRIMARY outcome
Timeframe: From date of registration to date of death due to any cause, assessed up to 3 yearsPopulation: Eligible and analyzable participants
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed using the logrank test.
Outcome measures
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=56 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1
n=55 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
All Phase 1 Participants
Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
|
Phase II: PEGPH20 + mFOLFIRINOX
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Phase II: Overall Survival
|
14.4 months
Interval 9.2 to 18.0
|
7.7 months
Interval 4.5 to 10.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of registration to date of death due to any cause, assessed up to 3 yearsPopulation: Eligible and analyzable participants
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Outcome measures
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=56 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1
n=55 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
All Phase 1 Participants
Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
|
Phase II: PEGPH20 + mFOLFIRINOX
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) (Phase II)
|
6.2 months
Interval 3.7 to 10.2
|
4.3 months
Interval 2.4 to 5.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Participants with measurable disease
Objective tumor response rate (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=56 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1
n=55 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
All Phase 1 Participants
Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
|
Phase II: PEGPH20 + mFOLFIRINOX
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)
|
45 percent of participants
Interval 32.0 to 58.0
|
33 percent of participants
Interval 20.0 to 45.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration of treatment and follow up until death or 3 years post registrationPopulation: Patients who received at least one dose of protocol treatment. Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol treatment.
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living e.g. bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event
Outcome measures
| Measure |
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=5 Participants
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes;
Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours;
Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours;
Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours;
5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1
n=6 Participants
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes
Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours
Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours
Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours
5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
All Phase 1 Participants
n=54 Participants
Phase I participants that received PEGPH20 at the assigned dose for cycle 1.
|
Phase II: PEGPH20 + mFOLFIRINOX
n=51 Participants
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infusion related reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytosis
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ascites
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Depression
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
1 Participants
|
0 Participants
|
10 Participants
|
12 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
2 Participants
|
1 Participants
|
6 Participants
|
11 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal disorders - Other, specify
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions- Other
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
0 Participants
|
8 Participants
|
12 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Paresthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral motor neuropathy
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peritoneal infection
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Portal vein thrombosis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pulmonary hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Resp, thoracic and mediastinal disorders - Other
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Small intestine infection
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Spasticity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ventricular tachycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gallbladder obstruction
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 2 years of the end of the studyExplore correlation of maximum decrease in CA 19-9 levels to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 2 years of end of studyOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 2 years of end of studyOutcome measures
Outcome data not reported
Adverse Events
Phase II: mFOLFIRINOX
Serious events: 9 serious events
Other events: 52 other events
Deaths: 49 deaths
Phase II: PEGPH20 + mFOLFIRINOX
Serious events: 36 serious events
Other events: 50 other events
Deaths: 50 deaths
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
Serious events: 3 serious events
Other events: 4 other events
Deaths: 5 deaths
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase II: mFOLFIRINOX
n=54 participants at risk
Participants receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: PEGPH20 + mFOLFIRINOX
n=51 participants at risk
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=5 participants at risk
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes\_\_Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
n=6 participants at risk
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
13.7%
7/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
17.6%
9/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
17.6%
9/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Death NOS
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Fatigue
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Fever
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Infusion related reaction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Hepatobiliary disorders
Hepatobiliary disorders-Other
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Device related infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Lung infection
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Sepsis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Skin infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Platelet count decreased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Weight loss
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Transient ischemic attacks
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Thromboembolic event
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
21.6%
11/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
Other adverse events
| Measure |
Phase II: mFOLFIRINOX
n=54 participants at risk
Participants receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase II: PEGPH20 + mFOLFIRINOX
n=51 participants at risk
Participants receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\_\_PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 and Day 3/4
n=5 participants at risk
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes\_\_Oxaliplatin, 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin, 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan, 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil (5-FU), 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
Phase I: mFOLFIRINOX + PEGPH20, 3 ug/kg on Day 1 Only
n=6 participants at risk
PEGPH20: 3 ug/kg on Day 1, IV over 15 minutes\_\_Oxaliplatin: 85 mg/m\^2, on Day 2, IV over 2 hours\_\_Leucovorin: 400 mg/m\^2, on Day 2, IV over 2 hours\_\_Irinotecan: 180 mg/m\^2, on Day 2, IV over 1.5 hours\_\_5-fluorouracil: 2,400 mg/m\^2, Days 2-4, IV over 46 hours
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
12/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
19.6%
10/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
36/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
72.5%
37/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
66.7%
4/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Cardiac disorders-Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Chest pain - cardiac
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Endocrine disorders
Endocrine disorders-Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Eye disorders
Blurred vision
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Eye disorders
Dry eye
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Eye disorders
Eye disorders-Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Eye disorders
Eye pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Eye disorders
Floaters
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
27/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
43.1%
22/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Ascites
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Bloating
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
37.0%
20/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
31.4%
16/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
60.0%
3/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
66.7%
4/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
75.9%
41/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
74.5%
38/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
80.0%
4/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
66.7%
4/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.8%
8/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Flatulence
|
14.8%
8/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Gastroparesis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
18.5%
10/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
21.6%
11/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
72.2%
39/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
76.5%
39/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
66.7%
4/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
26/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
45.1%
23/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Chills
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Edema face
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Edema limbs
|
18.5%
10/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
39.2%
20/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Edema trunk
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Fatigue
|
77.8%
42/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
78.4%
40/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
80.0%
4/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
83.3%
5/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Fever
|
13.0%
7/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Flu like symptoms
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Gait disturbance
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
General disorders and admin site conditions - Other
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Infusion related reaction
|
13.0%
7/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
15.7%
8/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Localized edema
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Malaise
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
General disorders
Pain
|
22.2%
12/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
19.6%
10/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Bronchial infection
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Enterocolitis infectious
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Eye infection
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Hepatic infection
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Infections and infestations-Other
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Mucosal infection
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Otitis media
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Upper respiratory infection
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
5/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Infections and infestations
Vaginal infection
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
18/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
37.3%
19/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Alkaline phosphatase increased
|
44.4%
24/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
47.1%
24/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
31.5%
17/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
35.3%
18/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Blood bilirubin increased
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Creatinine increased
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
GGT increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
INR increased
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Investigations-Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Lymphocyte count decreased
|
14.8%
8/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
13.7%
7/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
16.7%
9/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Platelet count decreased
|
50.0%
27/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
43.1%
22/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
Weight loss
|
33.3%
18/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
52.9%
27/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Investigations
White blood cell decreased
|
18.5%
10/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
17.6%
9/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.3%
25/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
51.0%
26/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
60.0%
3/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.8%
15/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.7%
22/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
47.1%
24/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
44.4%
24/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
51.0%
26/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.3%
5/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
47.1%
24/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
51.9%
28/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
37.3%
19/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
83.3%
5/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.5%
17/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
35.3%
18/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
13.7%
7/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.1%
13/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
15.7%
8/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.4%
11/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
37.3%
19/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
80.0%
4/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Ataxia
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Concentration impairment
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Dizziness
|
16.7%
9/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
17.6%
9/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Dysarthria
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Dysesthesia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Dysgeusia
|
22.2%
12/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
25.5%
13/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
60.0%
3/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
50.0%
3/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Facial muscle weakness
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Headache
|
16.7%
9/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Nervous system disorders-Other
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Paresthesia
|
18.5%
10/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
13.7%
7/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
40.0%
2/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
59.3%
32/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
47.1%
24/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
80.0%
4/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
66.7%
4/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Syncope
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Nervous system disorders
Tremor
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Anxiety
|
18.5%
10/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Confusion
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Depression
|
13.0%
7/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Insomnia
|
16.7%
9/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
19.6%
10/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Hematuria
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
6/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.3%
5/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
11.8%
6/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
5/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
5.9%
3/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
7.8%
4/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
33.3%
2/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.0%
7/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
7.4%
4/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
2/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Flushing
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Hematoma
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Hot flashes
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
9.8%
5/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Hypertension
|
16.7%
9/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
15.7%
8/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
20.0%
1/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Hypotension
|
9.3%
5/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
3.9%
2/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
16.7%
1/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
3/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
2.0%
1/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
|
Vascular disorders
Vascular disorders-Other
|
1.9%
1/54 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/51 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/5 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
0.00%
0/6 • Duration of treatment and follow up until death or 3 years post registration
Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60