Trial Outcomes & Findings for Everolimus in Combination With Imatinib in Patients With Glivec Refractory/Resistant Gastrointestinal Stromal Tumors (NCT NCT01275222)
NCT ID: NCT01275222
Last Updated: 2021-06-25
Results Overview
Assessed safety and tolerability of the combination administration of RAD001 and imatinib when given to patients with imatinib-refractory gastro-intestinal stromal tumors (GIST) by number of participants with adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
117 participants
Primary outcome timeframe
4 - 8 weeks
Results posted on
2021-06-25
Participant Flow
This trial was a Phase I/II study, following a sequential 2-part design. The 1st part was designed to assess whether there was a pharmacokinetic interaction between Glivec/Gleevec and RAD001. The 2nd part was designed to assess the potential efficacy of the combination in Glivec/Gleevec-resistant GIST patients in 2 strata of patients.
An estimated maximum of 130 patients was planned to be enrolled into the study. In Phase I, there were 42 patients enrolled. In Phase II, there were 75 patients enrolled. 3 patients were excluded from all analyses due to a major protocol violation.
Participant milestones
| Measure |
Phase l: RAD001 20mg/Week
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Phase l by Treatment
STARTED
|
13
|
13
|
5
|
11
|
0
|
0
|
|
Phase l by Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase l by Treatment
NOT COMPLETED
|
13
|
13
|
5
|
11
|
0
|
0
|
|
Phase ll by Stratum
STARTED
|
0
|
0
|
0
|
0
|
28
|
47
|
|
Phase ll by Stratum
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase ll by Stratum
NOT COMPLETED
|
0
|
0
|
0
|
0
|
28
|
46
|
Reasons for withdrawal
| Measure |
Phase l: RAD001 20mg/Week
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Phase l by Treatment
Adverse Event
|
1
|
4
|
2
|
3
|
0
|
0
|
|
Phase l by Treatment
Abnormal laboratory value(s)
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase l by Treatment
Abnormal test procedure result(s)
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase l by Treatment
Disease progression
|
12
|
8
|
2
|
5
|
0
|
0
|
|
Phase l by Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase l by Treatment
Death
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Phase ll by Stratum
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
10
|
|
Phase ll by Stratum
Abnormal laboratory values
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase ll by Stratum
Disease progression
|
0
|
0
|
0
|
0
|
23
|
31
|
|
Phase ll by Stratum
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
3
|
|
Phase ll by Stratum
Death
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
Baseline characteristics by cohort
| Measure |
Phase l: RAD001 20mg/Week
n=13 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
n=5 Participants
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 Participants
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 Participants
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 5.25 • n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
52.2 Years
STANDARD_DEVIATION 14.11 • n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
53.8 Years
STANDARD_DEVIATION 11.95 • n=5 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
61.9 Years
STANDARD_DEVIATION 13.25 • n=11 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
55.6 Years
STANDARD_DEVIATION 13.16 • n=28 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
59.3 Years
STANDARD_DEVIATION 12.54 • n=47 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
55.3 Years
STANDARD_DEVIATION 11.80 • n=42 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
|
Sex: Female, Male
Female
|
2 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=11 Participants
|
7 Participants
n=28 Participants
|
16 Participants
n=47 Participants
|
34 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=13 Participants
|
10 Participants
n=13 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=11 Participants
|
21 Participants
n=28 Participants
|
31 Participants
n=47 Participants
|
83 Participants
n=117 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
12 Participants
n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
5 Participants
n=5 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
11 Participants
n=11 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
27 Participants
n=28 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
47 Participants
n=47 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
115 Participants
n=117 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
1 Participants
n=13 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
0 Participants
n=5 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
0 Participants
n=11 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
1 Participants
n=28 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
0 Participants
n=47 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
2 Participants
n=117 Participants • The Intent-to-treat population (ITT-population) consists of all patients who received at least one dose of RAD001 or Glivec/Gleevec in accordance to the study protocol.
|
PRIMARY outcome
Timeframe: 4 - 8 weeksPopulation: Safety Population: All patients (except for the 3 patients who did not meet the protocol inclusion/exclusion criteria) were included in the Safety population for Phase I. All patients were included in the Safety population for Phase II.
Assessed safety and tolerability of the combination administration of RAD001 and imatinib when given to patients with imatinib-refractory gastro-intestinal stromal tumors (GIST) by number of participants with adverse events.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=13 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
n=5 Participants
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 Participants
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 Participants
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs): Phase I & II
|
13 Participants
|
13 Participants
|
5 Participants
|
11 Participants
|
27 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: 6 - 8 weeksPopulation: Intent-to-treat (ITT) population: All patients (except for the 3 patients who did not meet the protocol inclusion/exclusion criteria) were included in the ITT population.
Assessed clinical efficacy of the combination regimen in this patient population per BOR by Overall response (CR + PR). Complete response: Disappearance of all target lesions; Partial response: ≥ 30% decrease in the sum of the longest diameter of target lesions compared to baseline (and not ≥20% increase compared to smallest sum).
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=13 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
n=5 Participants
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 Participants
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 Participants
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) as Assessed by Overall Response (Complete Response (CR) & Partial Response (PR)) - Phase I & II
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
1 Percentage of Participants
Interval 0.2 to 36.0
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
0.0 Percentage of Participants
Interval 0.0 to 0.0
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
1 Percentage of Participants
Interval 0.1 to 11.3
|
PRIMARY outcome
Timeframe: Part II Daily regimen: Baseline, Days 8, 15 and thereafter approximately every two months starting at month 3 whenever possiblePopulation: Pharmacokinetics (PK) population: The PK population included 18% of Stratum I patients and 47% of Stratum II patients
Assessed the pharmacokinetics (PK) of the combination administration of RAD001 and imatinib in this patient population.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=5 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=22 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 3: RAD001
|
19.900 ng/mL
Interval 19.9 to 19.9
|
12.750 ng/mL
Interval 7.62 to 23.3
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 9: Imatinib
|
—
|
899.0 ng/mL
Interval 295.0 to 1780.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 2: RAD001
|
24.300 ng/mL
Interval 24.3 to 24.3
|
12.100 ng/mL
Interval 5.8 to 17.2
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 9: RAD001
|
—
|
10.950 ng/mL
Interval 10.4 to 11.5
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Month 4: RAD001
|
—
|
7.840 ng/mL
Interval 6.9 to 10.3
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Baseline: Imatinib
|
472.00 ng/mL
Interval 472.0 to 472.0
|
501.50 ng/mL
Interval 402.0 to 1210.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 2: Imatinib
|
626.50 ng/mL
Interval 549.0 to 704.0
|
540.00 ng/mL
Interval 330.0 to 1970.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Week 3: Imatinib
|
572.00 ng/mL
Interval 203.0 to 590.0
|
718.00 ng/mL
Interval 412.0 to 4040.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Month 4: Imatinib
|
333.00 ng/mL
Interval 333.0 to 333.0
|
446.00 ng/mL
Interval 89.9 to 1350.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Month 6: Imatinib
|
181.00 ng/mL
Interval 181.0 to 181.0
|
2040.00 ng/mL
Interval 2040.0 to 2040.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Month 8: Imatinib
|
—
|
575.00 ng/mL
Interval 566.0 to 584.0
|
—
|
—
|
—
|
—
|
|
Trough Concentrations for RAD001 and for Imatinib - Phase II
Month 12: Imatinib
|
—
|
324.00 ng/mL
Interval 324.0 to 324.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: about 60 monthsPopulation: ITT population: All patients (except for the 3 patients who did not meet the protocol inclusion/exclusion criteria) were included in the ITT population for phase I. All patients were included in the ITT population for phase II.
Assessed clinical efficacy of the combination regimen in this patient population per Overall Survival (OS). Overall survival was defined as the time from date of start of treatment to date of death due to any cause. For patients still receiving study medication at the time of the analysis, survival was censored at the date of last examination. If a patient was not known to have died but was no longer continuing with study medication, survival was censored at the date of last contact.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=13 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
n=5 Participants
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 Participants
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 Participants
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) - Phase I & II
|
9.4 months
Interval 5.6 to 13.8
|
10.9 months
Interval 3.3 to
NA - insufficient number of participants with events
|
18.7 months
Interval 3.8 to
NA - insufficient number of participants with events
|
NA months
Interval 12.0 to
NA - insufficient number of participants with events
|
14.9 months
Interval 14.9 to
NA - insufficient number of participants with events
|
10.7 months
Interval 6.3 to 16.8
|
PRIMARY outcome
Timeframe: about 4 monthsPopulation: Per Protocol population: The per-protocol population included 82% of Stratum I patients and 75% of Stratum II patients.
Assessed clinical efficacy of the combination regimen in this patient population per Progression-free survival (PFS). Progression-free survival (PFS) was the time from date of start of treatment to the date of first documented progression or death due to any cause. Per protocol (PP) population includes patients with no known overall lesion response during 4 months +/- 2 weeks, or who later had response of CR/PR/stable disease (SD). PP population excludes patients with no known response during 4 months + / -2 weeks and no subsequent CR/PR/SD.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=23 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=35 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
4-Month Progression-free Survival (PFS) Rate - Phase II
|
17.4 Percentage of participants
Interval 5.0 to 38.8
|
37.1 Percentage of participants
Interval 21.5 to 55.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: about 60 monthsPopulation: ITT population: All patients were included in the ITT population for Phase II.
Assessed clinical efficacy of the combination regimen in this patient population per Progression-free survival (PFS). Progression-free survival (PFS) was the time from date of start of treatment to the date of first documented progression or death due to any cause. If a patient had not progressed or died, progression-free survival was censored at the time of last adequate tumor assessment. According to the study protocol no tumor assessments were performed after discontinuation of treatment with study drug. Therefore, for all patients who discontinued treatment without a documented progression but died thereafter, death was considered as PFS event only if it occurred within the regular safety follow-up of 28 days after discontinuation. Otherwise, the PFS time was censored at the last adequate tumor assessment.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=28 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=47 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) - Phase II
|
1.9 months
Interval 1.8 to 3.7
|
3.5 months
Interval 1.9 to 5.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: about 60 monthsPopulation: Pharmacodynamic population: Molecular pathology and pharmacogenomic assessments were planned, but not carried out due to an alternative therapy that became available after the initiation of this study.
assess mTOR pathway activity before treatment, and inhibition of mTOR pathway activity during treatment as a predictive factor of response, as shown by molecular pathological examination of the tumor.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: about 60 monthsPopulation: Pharmacodynamic population: Molecular pathology and pharmacogenomic assessments were planned, but not carried out due to an alternative therapy that became available after the initiation of this study.
assess the relationship between drug-induced changes in the principal molecular marker of intratumoral mTOR activity and changes in other molecular markers of tumoral activity (e.g. indicators of pathway activity, cell proliferation and apoptosis).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: about 60 monthsPopulation: PET scans at baseline and as follow-up were planned to assess functional changes in tumors for patients on treatment. This analysis was not carried out due to alternative therapy that became available after the initiation of this study.
assess the relationship between drug-induced changes in tumoral metabolism, as shown by functional imaging with 18F-fluorodeoxyglucose positron emission tomography (FDC-PET), with clinical outcome and changes in molecular pathology.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: approx. 35.52 months, approx. 70 monthsPopulation: ITT population: All patients (except for the 3 patients who did not meet the protocol inclusion/exclusion criteria) were included in the ITT population for phase I. All patients were included in the ITT population for phase II.
On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for the phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the phase II part). Deaths post treatment survival follow up were collected after the on treatment period, up to 70 months.
Outcome measures
| Measure |
Phase l: RAD001 20mg/Week
n=13 Participants
RAD001 20 mg was given once a week.
|
Phase l: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 5mg/Day + Glivec 600mg/Day
n=5 Participants
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase l: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 Participants
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 Participants
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 Participants
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
All Collected Deaths
Total Deaths
|
12 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
22 Participants
|
|
All Collected Deaths
Deaths on-treatment
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
Phase I - RAD001 20mg/Week ++ Glivec 600mg/Day
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Phase I: RAD001 2.5mg/Day + Glivec 600mg/Day
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase I: RAD001 5mg/Day + Glivec 600mg/Day
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase I: RAD001 2.5mg/Day + Glivec 800mg/Day
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
Serious events: 11 serious events
Other events: 27 other events
Deaths: 0 deaths
Phase ll: Stratum ll (Post Second-line Therapy)
Serious events: 25 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - RAD001 20mg/Week ++ Glivec 600mg/Day
n=13 participants at risk
RAD001 20 mg was given in combination with Glivec/Gleevec 600mg/day
|
Phase I: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 participants at risk
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase I: RAD001 5mg/Day + Glivec 600mg/Day
n=5 participants at risk
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase I: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 participants at risk
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 participants at risk
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 participants at risk
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.0%
8/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Asthenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Catheter related complication
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Disease progression
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Drug interaction
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Fatigue
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
General physical health deterioration
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Malaise
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Multi-organ failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Morganella infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood creatinine increased
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Haemoglobin decreased
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Shock
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
Other adverse events
| Measure |
Phase I - RAD001 20mg/Week ++ Glivec 600mg/Day
n=13 participants at risk
RAD001 20 mg was given in combination with Glivec/Gleevec 600mg/day
|
Phase I: RAD001 2.5mg/Day + Glivec 600mg/Day
n=13 participants at risk
RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase I: RAD001 5mg/Day + Glivec 600mg/Day
n=5 participants at risk
RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day.
|
Phase I: RAD001 2.5mg/Day + Glivec 800mg/Day
n=11 participants at risk
RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day.
|
Phase ll - Stratum l (First-line Resistant/Refractory): RAD001 2.5mg/Day + Glivec 600mg/Day
n=28 participants at risk
All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
Phase ll: Stratum ll (Post Second-line Therapy)
n=47 participants at risk
All post second-line therapy patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
46.2%
6/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
53.8%
7/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
60.0%
3/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
36.4%
4/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
42.9%
12/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
46.8%
22/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.9%
7/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.8%
6/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Eye oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Eye swelling
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
36.4%
4/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.0%
8/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Orbital oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
38.5%
5/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
39.3%
11/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
25.5%
12/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.9%
7/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
61.5%
8/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
38.5%
5/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
63.6%
7/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
42.9%
12/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
36.2%
17/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
21.4%
6/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
61.5%
8/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
100.0%
5/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
63.6%
7/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
42.9%
12/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
34.0%
16/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.9%
7/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
60.0%
3/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
45.5%
5/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
21.4%
6/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
29.8%
14/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Asthenia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.9%
7/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Chest pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Chills
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Face oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Fatigue
|
69.2%
9/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
61.5%
8/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
81.8%
9/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
53.6%
15/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
34.0%
16/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
General physical health deterioration
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Malaise
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.8%
6/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Oedema
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Oedema peripheral
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
72.7%
8/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
28.6%
8/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
36.2%
17/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pitting oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pyrexia
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
38.5%
5/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
60.0%
3/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
19.1%
9/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Temperature intolerance
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Hepatobiliary disorders
Hepatic pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Conjunctivitis infective
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Infection
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
36.4%
4/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.7%
3/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Sepsis
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Tooth abscess
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Weight decreased
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
60.0%
3/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
21.4%
6/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.0%
8/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Weight increased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
38.5%
5/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
45.5%
5/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
21.4%
6/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
34.0%
16/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
45.5%
5/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.4%
11/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.3%
3/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Ageusia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.3%
4/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
28.6%
8/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.8%
6/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Sinus headache
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Distractibility
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
60.0%
3/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Nervousness
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.7%
3/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Nipple pain
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Paraesthesia of genital male
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Prostatic intraepithelial neoplasia
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
46.2%
6/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.7%
3/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
14.9%
7/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
23.1%
3/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.8%
6/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.7%
3/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.3%
2/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
10.6%
5/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.8%
6/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
40.0%
2/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
3.6%
1/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
6.4%
3/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.5%
4/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
9.1%
1/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.1%
2/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
2.1%
1/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
4/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
20.0%
1/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
17.9%
5/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
27.7%
13/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
7.7%
1/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
18.2%
2/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Hypertension
|
15.4%
2/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/13 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/5 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/11 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/28 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/47 • On-treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 35.52 months (treatment duration ranged from 0.36 to to 35.52 months for Phase I part) and a maximum duration of 21.88 months (treatment duration of 0.16 to 21.88 months for the Phase II part).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER