Trial Outcomes & Findings for JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors (NCT NCT02904226)
NCT ID: NCT02904226
Last Updated: 2023-07-03
Results Overview
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
242 participants
Primary outcome timeframe
46.3 months
Results posted on
2023-07-03
Participant Flow
The protocol enrollment number of 242 is the number of participants who signed the ICF. The number that Started the Participant flow module (218) are those subjects who received any amount of study drug (JTX-2011 and/or nivolumab and/or ipilimumab and/or pembrolizumab). The difference between these two values (24) are the number of patients who screen failed.
Participant milestones
| Measure |
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
31
|
30
|
100
|
11
|
0
|
6
|
0
|
|
Overall Study
COMPLETED
|
0
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
29
|
30
|
96
|
11
|
0
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors
Baseline characteristics by cohort
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
—
|
2 Participants
n=115 Participants
|
—
|
141 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
—
|
4 Participants
n=115 Participants
|
—
|
77 Participants
n=8 Participants
|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 10.94 • n=93 Participants
|
56.2 years
STANDARD_DEVIATION 9.87 • n=4 Participants
|
64.4 years
STANDARD_DEVIATION 10.57 • n=27 Participants
|
61.1 years
STANDARD_DEVIATION 9.65 • n=483 Participants
|
58.8 years
STANDARD_DEVIATION 9.95 • n=36 Participants
|
—
|
65.7 years
STANDARD_DEVIATION 8.77 • n=115 Participants
|
—
|
60.8 years
STANDARD_DEVIATION 10.22 • n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
—
|
3 Participants
n=115 Participants
|
—
|
99 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
—
|
3 Participants
n=115 Participants
|
—
|
119 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
91 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
—
|
6 Participants
n=115 Participants
|
—
|
196 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
—
|
6 Participants
n=115 Participants
|
—
|
163 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
—
|
0 Participants
n=115 Participants
|
—
|
28 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
31 participants
n=4 Participants
|
30 participants
n=27 Participants
|
100 participants
n=483 Participants
|
11 participants
n=36 Participants
|
—
|
6 participants
n=115 Participants
|
—
|
218 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
|
38 Participants
|
31 Participants
|
30 Participants
|
98 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
|
17 Participants
|
8 Participants
|
14 Participants
|
43 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
|
10 Participants
|
16 Participants
|
8 Participants
|
32 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 46.3 monthsNumber of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
|
8 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 33 monthsPopulation: Part C and D did not have any participants analyzed for this outcome measure because DLT is only relevant to the Phase 1 parts of study (Part A, Part B, Part E and Part G).
Number of participants with at least one dose limiting toxicity (DLT)
Outcome measures
| Measure |
Part A (JTX-2011)
n=40 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 46.5 monthsPopulation: Response Evaluable Set: subjects who received any study drug and have a baseline tumor assessment, and either has at least one post-baseline tumor assessment scan and/or discontinued treatment due to death or disease progression The number of participants analyzed is zero for Part F and Part H because there were no participants enrolled in those two groups of the study
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Overall Response Rate
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 46.5 monthsDisease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Disease Control Rate
|
7 Participants
|
7 Participants
|
3 Participants
|
23 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 46.5 monthsProgression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Progression Free Survival
|
2.1 months
Interval 1.9 to 2.1
|
2.0 months
Interval 1.8 to 2.2
|
1.9 months
Interval 1.8 to 2.0
|
2.0 months
Interval 1.9 to 2.0
|
2.5 months
Interval 1.3 to 4.1
|
4.0 months
Interval 1.3 to 10.4
|
PRIMARY outcome
Timeframe: 46.5 monthsPopulation: The 95% CI is not estimable by Kaplan-Meier method for Part E since the probability of event was 0.
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
6 Month Landmark Progression Free Survival
|
10.0 Probability of event free at month 6 (%)
Interval 2.1 to 25.3
|
10.2 Probability of event free at month 6 (%)
Interval 2.0 to 26.5
|
4.1 Probability of event free at month 6 (%)
Interval 0.3 to 17.6
|
9.1 Probability of event free at month 6 (%)
Interval 3.8 to 17.3
|
0 Probability of event free at month 6 (%)
NA Explanation: The 95% CI is not estimable by Kaplan-Meier method since no patients are at risk by the 6 month landmark
|
33.3 Probability of event free at month 6 (%)
Interval 1.4 to 75.5
|
PRIMARY outcome
Timeframe: 46.5 monthsPercentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
12 Month Landmark Progression Free Survival
|
NA Probability of event free at month 12(%)
The 95% CI is not estimable by Kaplan-Meier method since no patients are at risk by the 12 month landmark
|
10.2 Probability of event free at month 12(%)
Interval 2.0 to 26.5
|
4.1 Probability of event free at month 12(%)
Interval 0.3 to 17.5
|
4.6 Probability of event free at month 12(%)
Interval 1.2 to 11.4
|
0 Probability of event free at month 12(%)
The 95% CI is not estimable by Kaplan-Meier method since no patients are at risk by the 12 month landmark
|
0 Probability of event free at month 12(%)
The 95% CI is not estimable by Kaplan-Meier method since no patients are at risk by the 12 month landmark
|
PRIMARY outcome
Timeframe: 46.5 monthsPercentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Landmark Overall Survival at 6 Months
|
69.4 Probability of event free at month 6 (%)
Interval 46.8 to 83.9
|
61.8 Probability of event free at month 6 (%)
Interval 40.4 to 77.5
|
47.9 Probability of event free at month 6 (%)
Interval 27.2 to 66.0
|
70.2 Probability of event free at month 6 (%)
Interval 59.1 to 78.8
|
77.8 Probability of event free at month 6 (%)
Interval 36.5 to 93.9
|
66.7 Probability of event free at month 6 (%)
Interval 19.5 to 90.4
|
PRIMARY outcome
Timeframe: 46.5 monthsPercentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Landmark Overall Survival at 12 Months
|
12.2 Probability of event free at month 12(%)
Interval 2.1 to 31.8
|
41.2 Probability of event free at month 12(%)
Interval 22.2 to 59.3
|
16.0 Probability of event free at month 12(%)
Interval 4.1 to 34.8
|
40.5 Probability of event free at month 12(%)
Interval 29.5 to 51.3
|
31.1 Probability of event free at month 12(%)
Interval 1.5 to 72.3
|
16.7 Probability of event free at month 12(%)
Interval 0.8 to 51.7
|
PRIMARY outcome
Timeframe: 46.5 monthsThe time from first dose date to the date of death for any cause
Outcome measures
| Measure |
Part A (JTX-2011)
n=38 Participants
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=29 Participants
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 Participants
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=90 Participants
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=9 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 Participants
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
7.6 months
Interval 5.4 to 10.3
|
8.9 months
Interval 4.7 to 12.7
|
4.9 months
Interval 3.1 to 9.2
|
9.5 months
Interval 7.2 to 12.0
|
9.3 months
Interval 1.9 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
8.2 months
Interval 2.9 to
Upper confidence limit is not estimable by Brookmeyer and Crowley method due to insufficient observed events.
|
Adverse Events
Part A (JTX-2011)
Serious events: 14 serious events
Other events: 38 other events
Deaths: 19 deaths
Part B (JTX-2011 + Nivolumab)
Serious events: 9 serious events
Other events: 31 other events
Deaths: 19 deaths
Part C (JTX-2011)
Serious events: 16 serious events
Other events: 30 other events
Deaths: 22 deaths
Part D (JTX-2011 + Nivolumab)
Serious events: 38 serious events
Other events: 98 other events
Deaths: 68 deaths
Part E (JTX-2011 + Ipilimumab)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 6 deaths
Part F (JTX-2011 + Ipilimumab)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part G (JTX-2011 + Pembrolizumab)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Part H (JTX-2011 + Pembrolizumab)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A (JTX-2011)
n=40 participants at risk
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 participants at risk
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 participants at risk
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 participants at risk
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 participants at risk
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 participants at risk
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Peritonitis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Klebsiella bacteraemia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Paraneoplastic pleural effusion
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Fatigue
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Asthenia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Sudden death
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Hypercalcaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Weight decreased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Psychiatric disorders
Mental status changes
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
Other adverse events
| Measure |
Part A (JTX-2011)
n=40 participants at risk
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
|
Part B (JTX-2011 + Nivolumab)
n=31 participants at risk
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part C (JTX-2011)
n=30 participants at risk
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
|
Part D (JTX-2011 + Nivolumab)
n=100 participants at risk
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
|
Part E (JTX-2011 + Ipilimumab)
n=11 participants at risk
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
|
Part G (JTX-2011 + Pembrolizumab)
n=6 participants at risk
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
45.2%
14/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
26.7%
8/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
32.0%
32/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
25.8%
8/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
23.3%
7/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.0%
16/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
7/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.9%
4/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
5/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.0%
18/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
27.3%
3/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
25.8%
8/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
20.0%
6/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
14.0%
14/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
36.4%
4/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
8/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
26.7%
8/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
8.0%
8/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.0%
12/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Proctalgia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Retching
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Fatigue
|
22.5%
9/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
32.3%
10/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
50.0%
15/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
37.0%
37/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
63.6%
7/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Pyrexia
|
15.0%
6/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.1%
5/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.3%
4/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
24.0%
24/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Chills
|
15.0%
6/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.0%
13/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Oedema peripheral
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
20.0%
6/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Chest pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
8/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.1%
5/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
10/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
29.0%
29/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
54.5%
6/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
50.0%
3/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
5/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
17.0%
17/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
50.0%
3/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.9%
4/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
8.0%
8/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
8.0%
8/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
27.3%
3/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
20.0%
6/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
7.0%
7/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.0%
9/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
5/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
20.0%
6/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
23.0%
23/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
19.4%
6/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
22.0%
22/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.0%
18/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.1%
5/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.0%
13/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
10/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
8.0%
8/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
5/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.3%
4/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.0%
12/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
5/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
14.0%
14/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.3%
4/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood creatinine increased
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Lymphocyte count decreased
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
White blood cell count decreased
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
26.7%
8/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.0%
13/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
13.0%
13/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Balance disorder
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.0%
9/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
5/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.0%
3/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.9%
4/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.0%
9/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.7%
3/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.0%
6/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
29.0%
9/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
10.0%
3/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.0%
16/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
18.2%
2/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
9/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
12.9%
4/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
23.3%
7/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
11.0%
11/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
27.3%
3/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
66.7%
4/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Psychiatric disorders
Insomnia
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
11.0%
11/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Psychiatric disorders
Confusional state
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Vascular disorders
Hypertension
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
7.0%
7/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.2%
1/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
3.3%
1/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
33.3%
2/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Vascular disorders
Hot flush
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
2.0%
2/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
16.7%
1/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Cardiac disorders
Tachycardia
|
7.5%
3/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.7%
2/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
5.0%
5/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
6.5%
2/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
4.0%
4/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Endocrine disorders
Hyerthyroidism
|
0.00%
0/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
1.0%
1/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
2.5%
1/40 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/31 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/30 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/100 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
9.1%
1/11 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
0.00%
0/6 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
—
0/0 • Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
|
Additional Information
Stew Kroll, Chief Development Officer
Jounce Therapeutics, Inc.
Phone: (650) 576-9679
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication ("pub.") can be restricted until the 1st to occur of (a) pub. of the clinical trial results, or (b) 18 mo's after the Primary Completion Date. Pub. rights depend on PI conducting the study in compliance with the Protocol, that the pub. is made in a recognized journal or conference, and makes use of all study data. The Sponsor can require removal of Sponsor's confidential information from any pub. and can defer pub. for up to an add'l 60 days to file a related patent application.
- Publication restrictions are in place
Restriction type: OTHER