Trial Outcomes & Findings for Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02353143)
NCT ID: NCT02353143
Last Updated: 2024-08-12
Results Overview
Identification of DLT defined as an adverse event occurring during the first treatment cycle, judged to be related to MEN1112 and meeting any of the following criteria: * Grade 3 non-haematological toxicity lasting more than 7 days * Grade ≥ 4 non-haematological toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
71 participants
Primary outcome timeframe
over 3 weeks after the first dose
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
Cohort 1
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
6
|
8
|
26
|
5
|
3
|
8
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
6
|
8
|
26
|
5
|
3
|
8
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
2
|
4
|
13
|
2
|
2
|
2
|
1
|
|
Overall Study
reason not specified
|
1
|
2
|
0
|
0
|
6
|
1
|
0
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
4
|
2
|
3
|
4
|
0
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
patient receiving other treatment for AML
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Dose limiting toxicity (DLT)
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cohort 1
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=8 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=26 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=8 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
32 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
39 Participants
|
|
Age, Continuous
|
69 years
n=99 Participants
|
55.6 years
n=107 Participants
|
53.8 years
n=206 Participants
|
68.6 years
n=7 Participants
|
69.2 years
n=31 Participants
|
77.6 years
n=30 Participants
|
58.3 years
n=3 Participants
|
49.1 years
n=6 Participants
|
56.8 years
n=114 Participants
|
63.6 years
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
32 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
6 participants
n=31 Participants
|
0 participants
n=30 Participants
|
2 participants
n=3 Participants
|
2 participants
n=6 Participants
|
1 participants
n=114 Participants
|
18 participants
|
|
Region of Enrollment
Italy
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=114 Participants
|
3 participants
|
|
Region of Enrollment
France
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
2 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
3 participants
n=114 Participants
|
6 participants
|
|
Region of Enrollment
Germany
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
5 participants
n=30 Participants
|
0 participants
n=3 Participants
|
2 participants
n=6 Participants
|
0 participants
n=114 Participants
|
8 participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
18 participants
n=31 Participants
|
0 participants
n=30 Participants
|
1 participants
n=3 Participants
|
4 participants
n=6 Participants
|
0 participants
n=114 Participants
|
36 participants
|
|
Weight
|
82.4 kilo
n=99 Participants
|
62.8 kilo
n=107 Participants
|
67.9 kilo
n=206 Participants
|
69.6 kilo
n=7 Participants
|
74 kilo
n=31 Participants
|
67.7 kilo
n=30 Participants
|
80.6 kilo
n=3 Participants
|
66.6 kilo
n=6 Participants
|
69.6 kilo
n=114 Participants
|
71.1 kilo
|
PRIMARY outcome
Timeframe: over 3 weeks after the first dosePopulation: For 'Single shot' administration: All patients receiving at least 1st \& 2nd drug administration (dose 0.1 and 0.3 mg/kg) or completing first Cycle (doses ≥ 0.6 mg/kg) and safety FU ≥ 6 days post last dose or having experienced a DLT For 'Ramp up'': All patients receiving at least 80% of the scheduled drug administration during 1st Cycle and with a safety FU ≥ 6 days post last dose or having experienced a DLT
Identification of DLT defined as an adverse event occurring during the first treatment cycle, judged to be related to MEN1112 and meeting any of the following criteria: * Grade 3 non-haematological toxicity lasting more than 7 days * Grade ≥ 4 non-haematological toxicity.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=18 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: over 3 weeks after the first dosePopulation: All subjects who received at last one dose of study treatment
Identification of MTD defined as one dose level below the Maximum Administered Dose (i.e. one dose level below the one at which ≥ 2 DLTs out of 6 treated patients occur).
Outcome measures
| Measure |
Cohort 1
n=71 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
1.7 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All patients who received at least one dose of study treatment by dose cohort
Number of patients with Treatment Emergent Signs and Symptoms (TESSs) by CTCAE severity grade \>3 and treatment related causality
Outcome measures
| Measure |
Cohort 1
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=8 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=26 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=8 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Emergent Signs and Symptoms (TESSs)
Patients with TESSs of CTCAE severity grade > or =3
|
3 participants
|
6 participants
|
6 participants
|
8 participants
|
26 participants
|
5 participants
|
3 participants
|
8 participants
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Treatment Emergent Signs and Symptoms (TESSs)
Patients with treatment related TESSs of CTCAE severity grade > or =3
|
2 participants
|
1 participants
|
4 participants
|
5 participants
|
11 participants
|
5 participants
|
1 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: end of intravenous infusionPopulation: patients with reliable PK blood samples available at the end of drug intravenous infusion for Cmax measurement
Cmax is the maximum serum drug concentration. For Cohort 1 to 3c (administration as 'one shot' infusion) Cmax is measured at the end of the first intravenous infusion ( 1 to 6 hours; depending on the individual subjects being the infusion frequently interrupted) For Cohort 1.7, 2.0 and 3.0 (dose administration as ramp up, divided in three sub-doses), Cmax is measured at the end of each out of 3 intravenous infusions
Outcome measures
| Measure |
Cohort 1
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=26 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
n=8 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
n=7 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
n=8 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MEN1112 Pharmacokinetic (PK) Parameter Cmax
|
0.22 mcg/mL
Standard Deviation 0.32
|
1.86 mcg/mL
Standard Deviation 2.06
|
3.29 mcg/mL
Standard Deviation 1.87
|
9.29 mcg/mL
Standard Deviation 5.07
|
2.67 mcg/mL
Standard Deviation 15.73
|
31.59 mcg/mL
Standard Deviation 18.18
|
2.65 mcg/mL
Standard Deviation 4.49
|
11.8 mcg/mL
Standard Deviation 2.91
|
18.57 mcg/mL
Standard Deviation 8.54
|
0.97 mcg/mL
Standard Deviation 2.18
|
7.62 mcg/mL
Standard Deviation 1.59
|
17.53 mcg/mL
Standard Deviation 6.6
|
1.26 mcg/mL
Standard Deviation 0.96
|
14.83 mcg/mL
Standard Deviation 8.57
|
39.73 mcg/mL
Standard Deviation 20.44
|
SECONDARY outcome
Timeframe: Dose 1- cycle 1Population: population with reliable PK parameters
AUC (0-t) is the area under the serum concentration-time curve from time 0 extrapolated to t time evaluated after the first dose
Outcome measures
| Measure |
Cohort 1
n=2 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=6 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=26 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
n=7 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
n=7 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
n=8 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
n=4 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MEN1112 PK Parameter AUC (0-t)
|
0.47 h*mcg/mL
Standard Deviation 0.5
|
79.48 h*mcg/mL
Standard Deviation 80.69
|
74.11 h*mcg/mL
Standard Deviation 88.45
|
346.8 h*mcg/mL
Standard Deviation 288.82
|
891.09 h*mcg/mL
Standard Deviation 642.63
|
1791.32 h*mcg/mL
Standard Deviation 1525.94
|
62.53 h*mcg/mL
Standard Deviation 87.94
|
200.15 h*mcg/mL
Standard Deviation 79.17
|
940.48 h*mcg/mL
Standard Deviation 686.59
|
5.87 h*mcg/mL
Standard Deviation 10.55
|
115.1 h*mcg/mL
Standard Deviation 33.66
|
843.53 h*mcg/mL
Standard Deviation 518.65
|
18.67 h*mcg/mL
Standard Deviation 14.63
|
194.91 h*mcg/mL
Standard Deviation 103.12
|
2385.21 h*mcg/mL
Standard Deviation 1956.83
|
SECONDARY outcome
Timeframe: dose 1 of cycle 1Population: all subjects with Pk concentrations allowing a reliable estimation of AUC (0-∞). NOTE: cohort 1 excluded because of non reliable estimation of AUC (0-∞)
AUC (0-∞) is the area under the serum concentration-time curve from time 0 extrapolated to infinite time
Outcome measures
| Measure |
Cohort 1
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=23 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=7 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MEN1112 PK Parameter AUC (0-∞)
|
99.89 h*mcg/mL
Standard Error 81.08
|
90.55 h*mcg/mL
Standard Error 91.67
|
370.69 h*mcg/mL
Standard Error 318.5
|
1321.55 h*mcg/mL
Standard Error 800.89
|
2220.48 h*mcg/mL
Standard Error 2009.55
|
1310.79 h*mcg/mL
Standard Error 1091.61
|
1516.51 h*mcg/mL
Standard Error 867.13
|
3894.85 h*mcg/mL
Standard Error 3352.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: dose 1 of cycle 1Population: PK population with drug measurment allowing reliable estimation of half-life (cohort 1 excluded since estimation of half-life as well as AUC 0-inf was not reliable)
t1/2 is the drug elimination half-life It is calculated on the first dose for all cohorts
Outcome measures
| Measure |
Cohort 1
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=7 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=23 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=7 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MEN1112 PK Parameter t1/2
|
18.63 hour
Standard Deviation 6.47
|
10.76 hour
Standard Deviation 9.22
|
21.21 hour
Standard Deviation 15.05
|
46.49 hour
Standard Deviation 34.25
|
38.34 hour
Standard Deviation 26.72
|
46.84 hour
Standard Deviation 35.2
|
72.51 hour
Standard Deviation 46.88
|
61.75 hour
Standard Deviation 30.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: According to the protocol, the efficacy analysis population includes all patients completing the first treatment cycle and having a post-cycle peripheral blood lab test and bone marrow aspirate.
CR rate at any time point, where CR is defined as: bone marrow blasts \<5%, absence of extramedullary disease, absolute neutrophil count \>1 x 109/L and platelet count \> 100 x 109/L. According to the protocol, the efficacy analysis population includes all patients completing the first treatment cycle and having a post-cycle peripheral blood lab test and bone marrow aspirate.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=15 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=1 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Complete Remission (CR) Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: According to the protocol, the efficacy analysis population includes all patients completing the first treatment cycle and having a post-cycle peripheral blood lab test and bone marrow aspirate.
best observed response at any time point to include Complete Remission (CR is defined as bone marrow blasts \< 5%, absence of extramedullary disease, absolute neutrophil count \> 1 x 109 / L and platelet count \> 100 x 109 / L) Complete Remission with incomplete blood count recovery \[CRi defined as all criteria for CR except residual thrombocytopenia (platelets \<100 x 109/L), and/or neutropenia (absolute neutrophil count \<1 x 109/L)\] Partial remission (PR defined as all haematological criteria for CR with bone marrow blasts 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=15 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=1 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall Survival (OS) is the time from the date of the first drug administration to the date of death from any cause. If the fatal event does not occur during the study, the overall survival time is censored at the date when the patient was last known to be alive. The overall survival (OS) is calculated on 29 patients (72.5%) out of 40 belonging to the efficacy population. OS(measured in days) is reported as mean (and range)
Overall Survival (OS) is the time from the date of the first drug administration to the date of death from any cause. If the fatal event does not occur during the study, the overall survival time is censored at the date when the patient was last known to be alive. The overall survival (OS) is calculated on 29 patients (72.5%) out of 40 belonging to the efficacy population. Results are reported as mean (and range) days
Outcome measures
| Measure |
Cohort 1
n=2 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2
n=4 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3
n=5 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b
n=15 Participants
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c
n=3 Participants
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7
n=1 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0
n=3 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0
n=2 Participants
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
Cohort 2.0 (0.1 mg Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- first dose (0.1 mg) of the 3 ramp total dose
|
Cohort 2.0 (0.7 Out of 2.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- second dose (0.7 mg) of the 3 ramp total dose
|
Cohort 2 (1.2 Out of 2.0 mg)
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg- third dose (1.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (0.2 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- first dose (0.2 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.0 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- second dose (1.0 mg) of the 3 ramp total dose
|
Cohort 3.0 (1.8 Out of 3.0 mg/kg)
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg- third dose (1.8 mg) of the 3 ramp total dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
33 day
Interval 33.0 to 33.0
|
56.5 day
Interval 46.0 to 67.0
|
76.8 day
Interval 30.0 to 123.0
|
47 day
Interval 33.0 to 73.0
|
55.2 day
Interval 24.0 to 129.0
|
92 day
Interval 76.0 to 108.0
|
30 day
Interval 30.0 to 30.0
|
52.5 day
Interval 29.0 to 76.0
|
37 day
Interval 28.0 to 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 64 daysPopulation: Analysis of immunogenicity was not done in any patients participating to the study, since no clinical benefit was detected in any patients under the experimental conditions adopted in the study; the study was terminated
Incidence of anti-MEN1112 auto-antibodies
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (0.1 mg/kg)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 2 (0.3 mg/kg)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 4 deaths
Cohort 2b (0.6 mg/kg)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 5 deaths
Cohort 3 (1.0 mg/kg)
Serious events: 8 serious events
Other events: 8 other events
Deaths: 8 deaths
Cohort 3b (1.7 mg/kg)
Serious events: 25 serious events
Other events: 26 other events
Deaths: 17 deaths
Cohort 3c (2.5 mg/kg)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
Cohort 1.7 Ramp up
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2.0 Ramp up
Serious events: 8 serious events
Other events: 8 other events
Deaths: 5 deaths
Cohort 3.0 Ramp up
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cohort 1 (0.1 mg/kg)
n=4 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2 (0.3 mg/kg)
n=7 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b (0.6 mg/kg)
n=6 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3 (1.0 mg/kg)
n=8 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b (1.7 mg/kg)
n=26 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c (2.5 mg/kg)
n=5 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7 Ramp up
n=3 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0 Ramp up
n=8 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0 Ramp up
n=4 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
42.9%
3/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
53.8%
14/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Discomfort
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Escherichia bacteraemia
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Parotitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
40.0%
2/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
4/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
Other adverse events
| Measure |
Cohort 1 (0.1 mg/kg)
n=4 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.1 mg/kg
|
Cohort 2 (0.3 mg/kg)
n=7 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.3 mg/kg
|
Cohort 2b (0.6 mg/kg)
n=6 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 0.6 mg/kg
|
Cohort 3 (1.0 mg/kg)
n=8 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 1.0 mg/kg
|
Cohort 3b (1.7 mg/kg)
n=26 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 1.7 mg/kg
|
Cohort 3c (2.5 mg/kg)
n=5 participants at risk
MEN1112 given as "one shot" infusion at the dosage of 2.5 mg/kg
|
Cohort 1.7 Ramp up
n=3 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 1.7 mg/kg
|
Cohort 2.0 Ramp up
n=8 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 2.0 mg/kg
|
Cohort 3.0 Ramp up
n=4 participants at risk
MEN1112 given as "ramp-up" infusions at the dosage of 3.0 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
4/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
42.3%
11/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
80.0%
4/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
23.1%
6/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
34.6%
9/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Eye disorders
Intraocular haematoma
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
23.1%
6/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
40.0%
2/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
23.1%
6/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
30.8%
8/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Catheter site extravasation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Chest pain
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Chills
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Induration
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Oedema
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
57.1%
4/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
4/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Hepatobiliary disorders
Biliary dilatation
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Fungal rhinitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Gingivitis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Orchitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Haemodilution
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
75.0%
3/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
42.9%
3/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
57.7%
15/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
60.0%
3/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Interleukin level increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Procalcitonin increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Prothrombin level decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
40.0%
2/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
4/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
30.8%
8/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
37.5%
3/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
23.1%
6/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
3/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
66.7%
2/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Central-alveolar hypoventilation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Clonus
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
42.9%
3/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
2/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
19.2%
5/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
50.0%
2/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Product Issues
Device dislocation
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Psychiatric disorders
Nervousness
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
2/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
28.6%
2/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
15.4%
4/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
12.5%
1/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
3.8%
1/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
11.5%
3/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
20.0%
1/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
14.3%
1/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
7.7%
2/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
33.3%
1/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
25.0%
1/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/7 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
16.7%
1/6 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/26 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/5 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/3 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/8 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
0.00%
0/4 • Adverse Events were to be collected for 180 days (i.e. from Informed Consent signature to the End of Study Visit) or 70 days after last study drug administration whichever occurs last.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting the results of this study for publication or presentation, the Investigator will allow Menarini Ricerche S.p.A. at least 30-day time to review and comment upon the publication manuscript. Menarini Ricerche S.p.A.
- Publication restrictions are in place
Restriction type: OTHER