Trial Outcomes & Findings for First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors (NCT NCT02937116)

NCT ID: NCT02937116

Last Updated: 2022-10-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

233 participants

Primary outcome timeframe

Up to 28 days in Cycle 1

Results posted on

2022-10-14

Participant Flow

Participant milestones

Participant milestones
Measure
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Overall Study
STARTED
3
3
3
3
22
87
37
21
20
20
7
7
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
3
3
3
3
22
87
37
21
20
20
7
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Total
n=233 Participants
Total of all reporting groups
Age, Continuous
44.33 Years
STANDARD_DEVIATION 17.010 • n=5 Participants
46 Years
STANDARD_DEVIATION 15.524 • n=7 Participants
48 Years
STANDARD_DEVIATION 6.557 • n=5 Participants
50 Years
STANDARD_DEVIATION 16.093 • n=4 Participants
49.13 Years
STANDARD_DEVIATION 13.061 • n=21 Participants
52.27 Years
STANDARD_DEVIATION 11.280 • n=8 Participants
55.35 Years
STANDARD_DEVIATION 11.201 • n=8 Participants
60.52 Years
STANDARD_DEVIATION 6.539 • n=24 Participants
62.30 Years
STANDARD_DEVIATION 6.951 • n=42 Participants
58.20 Years
STANDARD_DEVIATION 8.600 • n=42 Participants
62.86 Years
STANDARD_DEVIATION 4.140 • n=42 Participants
49.29 Years
STANDARD_DEVIATION 11.912 • n=42 Participants
54.54 Years
STANDARD_DEVIATION 11.291 • n=36 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
7 Participants
n=21 Participants
30 Participants
n=8 Participants
6 Participants
n=8 Participants
5 Participants
n=24 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
61 Participants
n=36 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
15 Participants
n=21 Participants
57 Participants
n=8 Participants
31 Participants
n=8 Participants
16 Participants
n=24 Participants
19 Participants
n=42 Participants
18 Participants
n=42 Participants
6 Participants
n=42 Participants
5 Participants
n=42 Participants
172 Participants
n=36 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
22 Participants
n=21 Participants
87 Participants
n=8 Participants
37 Participants
n=8 Participants
21 Participants
n=24 Participants
20 Participants
n=42 Participants
20 Participants
n=42 Participants
7 Participants
n=42 Participants
7 Participants
n=42 Participants
233 Participants
n=36 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
Region of Enrollment
China
3 participants
n=5 Participants
3 participants
n=7 Participants
3 participants
n=5 Participants
3 participants
n=4 Participants
22 participants
n=21 Participants
87 participants
n=8 Participants
37 participants
n=8 Participants
21 participants
n=24 Participants
20 participants
n=42 Participants
20 participants
n=42 Participants
7 participants
n=42 Participants
7 participants
n=42 Participants
233 participants
n=36 Participants

PRIMARY outcome

Timeframe: Up to 28 days in Cycle 1

Population: All participants in Parts A1 to A4 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of Sintilimab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of Sintilimab without experiencing DLT. Per protocol, cohort A to H were not analyzed.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Through out the study (up to 2 years)

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Number of All Study Participants Who Demonstrate a Tumor Response
17 Participants
0 Participants
1 Participants
0 Participants
1 Participants
1 Participants
13 Participants
5 Participants
13 Participants
11 Participants
3 Participants
1 Participants

PRIMARY outcome

Timeframe: Through out the study (up to 2 years)

Population: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator
85.0 percentage of participants
Interval 62.1 to 96.8
4.5 percentage of participants
Interval 0.1 to 22.8
14.9 percentage of participants
Interval 8.2 to 24.2
13.5 percentage of participants
Interval 4.5 to 28.8
61.9 percentage of participants
Interval 38.4 to 81.9
55.0 percentage of participants
Interval 31.5 to 76.9
42.9 percentage of participants
Interval 9.9 to 81.6
14.3 percentage of participants
Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: Through out the study (up to 2 years)

Population: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
PFS According to RECIST 1.1 as Assessed by Investigator
230.0 Days
Interval 189.0 to 287.0
62.0 Days
Interval 59.0 to 125.0
66.0 Days
Interval 64.0 to 95.0
84.0 Days
Interval 60.0 to 187.0
377.0 Days
Interval 92.0 to
PFS range upper limit of 95% CI not reached
194.0 Days
Interval 160.0 to 239.0
NA Days
Median PFS and PFS range lower and upper limit of 95% CI not reached (no disease progression by last progression assessment)
NA Days
Interval 68.0 to
Median PFS and PFS range upper limit of 95% CI not reached

SECONDARY outcome

Timeframe: Through out the study (up to 2 years)

Population: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
DOR According to RECIST 1.1 as Assessed by Investigator
181.0 Days
Interval 146.0 to 221.0
NA Days
Median DOR and DOR lower and upper limit not reached
NA Days
Interval 86.0 to
Median DOR and DOR upper limit not reached (no progressive disease by time of last disease assessment)
368.0 Days
Interval 190.0 to
DOR upper limit not reached
NA Days
Median DOR and DOR lower and upper limit not reached
170.5 Days
Interval 58.0 to
DOR upper limit not reached
NA Days
Median DOR and DOR lower and upper limit of 95% CI not reached
NA Days
Median DOR and DOR lower and upper limit of 95% CI not reached

SECONDARY outcome

Timeframe: Through out the study (up to 2 years)

Population: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
TTR According to RECIST 1.1 as Assessed by Investigator
63.0 Days
Interval 62.0 to 65.0
63.0 Days
TTR louwer and upper limit not reached
64.0 Days
Interval 61.0 to 70.0
63.0 Days
Interval 60.0 to 189.0
63.0 Days
Interval 62.0 to 120.0
62.0 Days
Interval 58.0 to 68.0
62.0 Days
Interval 62.0 to 63.0
62.0 Days
Interval 62.0 to 62.0

SECONDARY outcome

Timeframe: Through out the study

Population: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 Participants
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 Participants
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 Participants
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 Participants
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 Participants
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 Participants
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
OS for Participants
NA Days
Interval 287.0 to
Median OS and OS range upper limit not reached
518.0 Days
Interval 349.0 to
OS range upper limit not reached
342.0 Days
Interval 218.0 to 441.0
431.0 Days
Interval 196.0 to 562.0
566.0 Days
Interval 158.0 to
OS range upper limit not reached
461.0 Days
Interval 308.0 to
OS range upper limit not reached
NA Days
Median OS and OS range lower and upper limit of 95% CI not reached (no death by last assessment)
NA Days
Median OS and OS range lower and upper limit of 95% CI not reached (no death by last assessment)

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC 0-t data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis..

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
4800 h*ug/ml
Geometric Coefficient of Variation 8.2
12300 h*ug/ml
Geometric Coefficient of Variation 35.2
39800 h*ug/ml
Geometric Coefficient of Variation 14.5
10800 h*ug/ml
Geometric Coefficient of Variation 49.3

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants
21.9 ug/ml
Geometric Coefficient of Variation 11.3
69.7 ug/ml
Geometric Coefficient of Variation 12.2
220 ug/ml
Geometric Coefficient of Variation 13.4
54.6 ug/ml
Geometric Coefficient of Variation 50.5

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants
1.05 hours
Interval 1.05 to 1.08
2.07 hours
Interval 2.07 to 2.08
2.27 hours
Interval 1.1 to 2.33
1.93 hours
Interval 1.08 to 2.13

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available T1/2 data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration
17 Days
Geometric Coefficient of Variation 7.3
12.7 Days
Geometric Coefficient of Variation 44.6
12.5 Days
Geometric Coefficient of Variation 26.4
16.1 Days
Geometric Coefficient of Variation 32.6

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available volume of distribution data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Volume of Distribution of IBI308 in Plasma After Single Dose Administration
5.02 L
Geometric Coefficient of Variation 24.0
5.14 L
Geometric Coefficient of Variation 18.7
5.95 L
Geometric Coefficient of Variation 10.5
7.2 L
Geometric Coefficient of Variation 45.0

SECONDARY outcome

Timeframe: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Population: All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available clearance data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.

Outcome measures

Outcome measures
Measure
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 Participants
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 Participants
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 Participants
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 Participants
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Clearance of IBI308 in Plasma After Single Dose Administration
8.53 ml/h
Geometric Coefficient of Variation 20.7
11.7 ml/h
Geometric Coefficient of Variation 33.3
13.7 ml/h
Geometric Coefficient of Variation 15.9
12.9 ml/h
Geometric Coefficient of Variation 61.1

Adverse Events

Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths

Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths

Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths

MEL: Sintilimab 200mg Q3W (Cohort A)

Serious events: 0 serious events
Other events: 18 other events
Deaths: 12 deaths

Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)

Serious events: 18 serious events
Other events: 82 other events
Deaths: 57 deaths

NSCLC: Sintilimab 200mg Q3W (Cohort C)

Serious events: 11 serious events
Other events: 35 other events
Deaths: 25 deaths

nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)

Serious events: 3 serious events
Other events: 19 other events
Deaths: 9 deaths

scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)

Serious events: 9 serious events
Other events: 20 other events
Deaths: 8 deaths

Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)

Serious events: 6 serious events
Other events: 20 other events
Deaths: 3 deaths

Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)

Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths

Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)

Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 participants at risk
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 participants at risk
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 participants at risk
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 participants at risk
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 participants at risk
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 participants at risk
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 participants at risk
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 participants at risk
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 participants at risk
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
3.4%
3/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Oesophageal stenosis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Diarrhoea
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Functional gastrointestinal disorder
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Autoimmune colitis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Gallbladder pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Jaundice
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Pyrexia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.3%
2/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Death
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Biliary tract infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Lung infection
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Soft tissue infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Pneumonia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Pyopneumothorax
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Injury, poisoning and procedural complications
Tracheal haemorrhage
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Anaemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Bone marrow failure
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood bilirubin increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Amylase increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Platelet count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.0%
4/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Neutrophil count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Renal hydrocele
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Hypothyroidism
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.

Other adverse events

Other adverse events
Measure
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)
n=3 participants at risk
1mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)
n=3 participants at risk
3mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)
n=3 participants at risk
10mg/kg intravenous Q2W, will be continued until disease progression or unacceptable toxicity.
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)
n=3 participants at risk
200mg intravenous Q3W, will be continued until disease progression or unacceptable toxicity.
MEL: Sintilimab 200mg Q3W (Cohort A)
n=22 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)
n=87 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
NSCLC: Sintilimab 200mg Q3W (Cohort C)
n=37 participants at risk
Subjects received sintilimab 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)
n=21 participants at risk
Subjects received sintilimab 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)
n=20 participants at risk
Subjects received sintilimab 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)
n=20 participants at risk
Subjects received sintilimab 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)
n=7 participants at risk
Subjects received sintilimab 200mg in combination with Cisplatin 75mg/m2 intravenously Day 1 and Etoposide 100mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)
n=7 participants at risk
Subjects received sintilimab 200mg intravenously Day 1 in combination with Irinotecan 125mg/m2 intravenously Day 1 and 8, and 5-FU 1000mg/m2 intravenously Day 1-3 every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment.
Blood and lymphatic system disorders
Leukopenia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Anaemia
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.5%
37/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
27.0%
10/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
9/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
85.0%
17/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
60.0%
12/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
85.7%
6/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Neutrophilia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Blood and lymphatic system disorders
Thrombocytopenia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Arrhythmia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Atrioventricular block first degree
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Bundle branch block right
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Cardiac failure
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Palpitations
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Sinus bradycardia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Sinus tachycardia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
3.4%
3/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
21.6%
8/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Supraventricular extrasystoles
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Ventricular arrhythmia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Cardiac disorders
Ventricular extrasystoles
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Ear and labyrinth disorders
Hypoacusis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Goitre
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Hyperthyroidism
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Hypothyroidism
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.6%
4/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
30.0%
6/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Thyroid mass
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Endocrine disorders
Thyroiditis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Eye disorders
Conjunctival hyperaemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Eye disorders
Eyelid oedema
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Eye disorders
Xerophthalmia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Abdominal distension
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Abdominal pain upper
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Constipation
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
11.5%
10/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Diarrhoea
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
19.0%
4/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Dyspepsia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Flatulence
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Gastric dilatation
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Hyperchlorhydria
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Loose tooth
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Nausea
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
3.4%
3/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
9/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
40.0%
8/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
85.7%
6/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Retching
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Subileus
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Toothache
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Gastrointestinal disorders
Vomiting
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.6%
4/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
7/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
30.0%
6/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Asthenia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
26.4%
23/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
7/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.0%
5/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Chest discomfort
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Chest pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Chills
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Face oedema
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Fatigue
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Oedema peripheral
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Peripheral swelling
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
General disorders
Pyrexia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
18.2%
4/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
17.2%
15/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.2%
6/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
6/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
30.0%
6/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
100.0%
7/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Immune system disorders
Hypersensitivity
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Abdominal infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Gastroenteritis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Herpes zoster
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Influenza
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Lung infection
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Pneumonia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Respiratory tract infection
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Rhinitis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Sebaceous gland infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Skin infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Soft tissue infection
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Tonsillitis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Upper respiratory tract infection
100.0%
3/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Urinary tract infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Alanine aminotransferase increased
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.6%
3/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.3%
22/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
18.9%
7/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
7/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.0%
5/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Amylase increased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Aspartate aminotransferase increased
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
100.0%
3/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
22.7%
5/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
32.2%
28/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.2%
6/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
6/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.0%
5/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Bilirubin conjugated increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.6%
3/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.3%
2/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood albumin decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood alkaline phosphatase increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood bilirubin increased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
22.7%
5/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.1%
14/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood bilirubin unconjugated increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood cholesterol increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood creatine phosphokinase increased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood creatinine increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.3%
2/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood glucose increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.6%
3/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.0%
4/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood potassium decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood potassium increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood pressure increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood thyroid stimulating hormone decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
19.0%
4/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
22.7%
5/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
3.4%
3/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.2%
6/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood triglycerides increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
18.2%
4/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.6%
4/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood urea increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Blood uric acid increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
C-reactive protein increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Creatinine renal clearance increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Electrocardiogram QT prolonged
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Electrocardiogram T wave abnormal
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Electrocardiogram abnormal
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Electrocardiogram low voltage
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.2%
8/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
27.0%
10/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
19.0%
4/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.0%
4/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Glucose urine present
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Granulocyte count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Heart rate increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Lipase increased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
11.5%
10/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Lymphocyte count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Mean cell haemoglobin concentration decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
19.0%
4/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Neutrophil count decreased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
47.6%
10/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
80.0%
16/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
50.0%
10/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
71.4%
5/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
57.1%
4/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Neutrophil count increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Occult blood positive
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Platelet count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.0%
7/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
70.0%
14/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
80.0%
16/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Platelet count increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Procalcitonin increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Protein urine present
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Red blood cell count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Red blood cells urine positive
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.6%
3/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.3%
2/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Thyroid function test abnormal
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.7%
18/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Thyroxine decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Thyroxine free decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Thyroxine free increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Thyroxine increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Tri-iodothyronine decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Tri-iodothyronine free decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Tri-iodothyronine free increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.3%
2/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Urine ketone body present
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Weight decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
Weight increased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.2%
8/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
White blood cell count decreased
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
22.7%
5/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.1%
14/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
7/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
90.0%
18/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
50.0%
10/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
71.4%
5/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
71.4%
5/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
White blood cell count increased
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Investigations
White blood cells urine positive
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Abnormal loss of weight
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.2%
6/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
38.1%
8/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
40.0%
8/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
85.7%
6/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Glucose tolerance impaired
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypercholesterolaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hyperglycaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypernatraemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypertriglyceridaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hyperuricaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.0%
7/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypoalbuminaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
16.1%
14/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.0%
5/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypocalcaemia
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
11.5%
10/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypochloraemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypokalaemia
100.0%
3/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
12.6%
11/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypomagnesaemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
11.5%
10/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypophosphataemia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.7%
5/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Hypoproteinaemia
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.9%
13/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Metabolism and nutrition disorders
Metabolic alkalosis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Musculoskeletal and connective tissue disorders
Arthralgia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.1%
2/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.3%
9/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Musculoskeletal and connective tissue disorders
Myalgia
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Cholinergic syndrome
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Dizziness
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Headache
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Hypoaesthesia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Paraesthesia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Poor quality sleep
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Nervous system disorders
Syncope
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Psychiatric disorders
Breath holding
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Psychiatric disorders
Insomnia
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.8%
4/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
15.0%
3/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Haematuria
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Oliguria
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Proteinuria
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.3%
22/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.0%
4/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
28.6%
2/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
42.9%
3/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Renal and urinary disorders
Urethral pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.5%
1/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.0%
7/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.1%
3/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
2.7%
1/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
1/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.4%
2/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Eczema
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
14.3%
3/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Pruritus
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
8.0%
7/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
13.5%
5/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
23.8%
5/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
20.0%
4/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
25.0%
5/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Skin exfoliation
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Urticaria papular
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
5.0%
1/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Skin and subcutaneous tissue disorders
Vitiligo
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
18.2%
4/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
4.8%
1/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Vascular disorders
Hypertension
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
33.3%
1/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
66.7%
2/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
6.9%
6/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
9.5%
2/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
30.0%
6/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
Vascular disorders
Hypotension
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/3 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/22 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
1.1%
1/87 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/37 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/21 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
10.0%
2/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/20 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.
0.00%
0/7 • Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);
All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.

Additional Information

Yi Bo

Innovent Biologics (Suzhou) Co., Ltd. (seal)

Phone: +8613382419112

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place