Trial Outcomes & Findings for Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer (NCT NCT02575807)
NCT ID: NCT02575807
Last Updated: 2019-04-04
Results Overview
Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol: * any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4; * any use of systemic steroids; and/or * a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug. Hematological DLTs are defined as: * Grade 4 neutropenia lasting \>7 days; * Grade ≥3 febrile neutropenia; * Grade 4 anemia; * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting \>7 days or associated with bleeding; and/or * Dose delay \>7 days secondary to myelosuppression.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).
Results posted on
2019-04-04
Participant Flow
Participant milestones
| Measure |
Phase 1: CRS-207
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 colony forming units \[CFU\]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
CRS-207 administered in 3-week cycles, epacadostat (IDO) administered twice daily (BID).
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 milligrams \[mg\]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
16
|
2
|
4
|
|
Overall Study
Treated
|
8
|
4
|
16
|
1
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
16
|
2
|
4
|
Reasons for withdrawal
| Measure |
Phase 1: CRS-207
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 colony forming units \[CFU\]) administered by intravenous (IV) infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
CRS-207 administered in 3-week cycles, epacadostat (IDO) administered twice daily (BID).
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 milligrams \[mg\]) administered by mouth (PO) BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembrolizumab (pembro) administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
8
|
3
|
7
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
0
|
1
|
7
|
0
|
1
|
|
Overall Study
Terminated due to FDA clinical hold
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Terminated due to physician decision
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject ineligible - medical implant
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
Safety and Efficacy of CRS-207 With Epacadostat in Platinum Resistant Ovarian, Fallopian or Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 Participants
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 Participants
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 12.99 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
61.7 years
STANDARD_DEVIATION 5.13 • n=21 Participants
|
61.9 years
STANDARD_DEVIATION 9.39 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).Population: Analysis performed on subjects in the Phase 1 safety analysis set (SAF).
Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol: * any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4; * any use of systemic steroids; and/or * a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug. Hematological DLTs are defined as: * Grade 4 neutropenia lasting \>7 days; * Grade ≥3 febrile neutropenia; * Grade 4 anemia; * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting \>7 days or associated with bleeding; and/or * Dose delay \>7 days secondary to myelosuppression.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months.Population: Analysis performed on subjects in the Phase 1 safety analysis set.
Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher
|
6 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months.Population: Analysis performed on subjects in the Phase 2 safety analysis set.
Count of subjects in the Phase 2 cohorts with incidences of AEs.
Outcome measures
| Measure |
Phase 1: CRS-207
n=1 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=3 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 2: Adverse Events (AEs)
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks.Population: Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. One subject in the Phase 2 SAF did not complete ≥1 post-baseline response assessment and was therefore not evaluated for this outcome measure.
ORR was evaluated for Phase 2 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.
Outcome measures
| Measure |
Phase 1: CRS-207
n=1 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=2 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR)
Complete Response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Partial Response
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Stable Disease
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Progressive Disease
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Not Evaluable
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks.Population: Analysis performed on subjects in the Phase 2 SAF.
Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST.
Outcome measures
| Measure |
Phase 1: CRS-207
n=1 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=3 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
|
5.71 weeks
|
7.36 weeks
Interval 6.14 to 8.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks.Population: Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. Three subjects in the Phase 1 SAF did not complete ≥1 post-baseline response assessment and were therefore not evaluated for this outcome measure.
ORR was evaluated for Phase 1 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST), RECIST v1.1, and GCIG CA-125 criteria and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=13 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 1: Objective Response Rate (ORR) by mRECIST
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Objective Response Rate (ORR) by mRECIST
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Objective Response Rate (ORR) by mRECIST
Stable Disease
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Phase 1: Objective Response Rate (ORR) by mRECIST
Progressive Disease
|
7 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Phase 1: Objective Response Rate (ORR) by mRECIST
Not Evaluable
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeksPopulation: Analysis performed on subjects in the Phase 1 SAF.
Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death due to any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST, RECIST v1.1, and GCIG CA-125.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Phase 1: Progression Free Survival (PFS)
|
8.43 weeks
Interval 3.0 to 9.71
|
4.71 weeks
Interval 3.29 to 17.14
|
8.43 weeks
Interval 4.29 to 36.0
|
—
|
—
|
SECONDARY outcome
Timeframe: BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks.Population: Analysis performed on subjects in the Phase 1 and Phase 2 SAF.
The protocol-specified DCR was defined as the percentage of evaluable subjects with a BOR of CR or PR, or SD as determined by mRECIST, RECIST v1.1, and GCIG CA-125 criteria.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 Participants
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 Participants
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate (DCR)
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Disease Control Rate (DCR)
Stable Disease (SD)
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks.Population: No study subjects achieved CR or PR designation; therefore, per the final SAP DOR was not derived.
Number of weeks from date of CR or PR designation until PD designation, as determined by mRECIST, RECIST v1.1 and GCIG CA-125 criteria.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 Participants
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 Participants
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks.Population: Analysis performed on subjects in the Phase 1 and Phase 2 SAF.
Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive. For subjects lost to follow up, the last visit or last contact date where the subject is documented to be alive will be used to estimate last known date alive.
Outcome measures
| Measure |
Phase 1: CRS-207
n=8 Participants
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 Participants
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 Participants
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 Participants
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
49.07 weeks
Interval 4.71 to 69.29
|
30.00 weeks
Interval 18.71 to 88.71
|
27.00 weeks
Interval 18.14 to 51.29
|
9.29 weeks
|
18.43 weeks
Interval 10.43 to 18.57
|
Adverse Events
Phase 1: CRS-207
Serious events: 2 serious events
Other events: 8 other events
Deaths: 8 deaths
Phase 1: CRS-207/IDO 100 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1: CRS-207/IDO 300 mg
Serious events: 9 serious events
Other events: 16 other events
Deaths: 7 deaths
Phase 2: CRS-207/Pembro/IDO
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 2: CRS-207/Pembro
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: CRS-207
n=8 participants at risk
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 participants at risk
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 participants at risk
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 participants at risk
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 participants at risk
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Amylase increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Disease progression
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
Other adverse events
| Measure |
Phase 1: CRS-207
n=8 participants at risk
CRS-207 administered in 3-week cycles.
\* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 will be administered on Day 1 of each cycle. After 6 cycles, CRS-207 will be administered on Day 1 once every 6 weeks (every other cycle).
|
Phase 1: CRS-207/IDO 100 mg
n=4 participants at risk
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (100 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 1: CRS-207/IDO 300 mg
n=16 participants at risk
CRS-207 administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 1 of each cycle. After 6 cycles, CRS-207 administered on Day 1 once every 6 weeks (every other cycle).
* IDO (300 mg) administered PO BID, starting on Day 2 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro/IDO
n=1 participants at risk
CRS-207 and pembro administered in 3-week cycles, IDO administered BID.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
* IDO (300 mg) administered PO BID, starting on Day 3 of the first CRS-207 treatment cycle.
|
Phase 2: CRS-207/Pembro
n=3 participants at risk
CRS-207 and pembro administered in 3-week cycles.
* CRS-207 (1 x 10e9 CFU) administered by IV infusion. For Cycle 1 through Cycle 6, CRS-207 administered on Day 2 of each cycle. After 6 cycles, CRS-207 administered on Day 2 once every 6 weeks (every other cycle).
* Pembro (200 mg) administered by IV infusion on Day 1 in 3-week cycles.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
62.5%
10/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
6/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
56.2%
9/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
4/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
8/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
37.5%
6/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Lip blister
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Chills
|
87.5%
7/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
4/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
75.0%
12/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
3/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Pyrexia
|
87.5%
7/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
87.5%
14/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
66.7%
2/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Fatigue
|
37.5%
3/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
68.8%
11/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Early satiety
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Malaise
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Oedema
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Pain
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Catheter site pain
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Hunger
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
General disorders
Disease progression
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
62.5%
10/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
66.7%
2/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
37.5%
3/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
31.2%
5/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
31.2%
5/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
3/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
37.5%
6/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
75.0%
6/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
31.2%
5/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
31.2%
5/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
4/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Amylase increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Blood urea increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypotension
|
37.5%
3/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
50.0%
2/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
18.8%
3/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
25.0%
1/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Incontinence
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Micturition urgency
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
Tachycardia
|
25.0%
2/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Cardiac disorders
Bradycardia
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Ear and labyrinth disorders
Ear discomfort
|
12.5%
1/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
12.5%
2/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
33.3%
1/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/4 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
6.2%
1/16 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
100.0%
1/1 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
0.00%
0/3 • Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 30 days following the last dose of study drug, an average of 3 months. Subjects were followed for survival until withdrawal of consent, loss to follow-up, death, or study termination (whichever is first), an average of 35 weeks.
AEs reported for the Safety Analysis Set (SAF). Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction is that study results will first be published in a joint multi-center paper unless (a) written confirmation is provided to the site or PI indicating that there will be no multi-center publication, or (b) at least 12 months have passed after the completion of data analysis at all study sites. Publications will be submitted for sponsor review ≥ 45 days prior to the publication date. Sponsor cannot require changes to the communication or extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER