Trial Outcomes & Findings for Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma (NCT NCT03267940)
NCT ID: NCT03267940
Last Updated: 2020-02-07
Results Overview
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
85 participants
Primary outcome timeframe
From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)
Results posted on
2020-02-07
Participant Flow
The study was conducted in 2 portions: Run-in portion and Expansion portion.
The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
Participant milestones
| Measure |
Run-in Portion: PEGCISGEM
Participants received 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m\^2) of cisplatin (CIS) plus 1000 mg/m\^2 of gemcitabine (GEM) administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg atezolizumab (ATEZO) (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
|
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Run-in Portion (Max. Exposure: 508 Days)
STARTED
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
Received at Least 1 Dose of Study Drug
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
NOT COMPLETED
|
8
|
7
|
0
|
0
|
0
|
0
|
|
Expansion (Maximum Exposure: 421 Days)
STARTED
|
0
|
0
|
24
|
22
|
11
|
10
|
|
Expansion (Maximum Exposure: 421 Days)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
24
|
22
|
11
|
10
|
|
Expansion (Maximum Exposure: 421 Days)
COMPLETED
|
0
|
0
|
3
|
0
|
1
|
0
|
|
Expansion (Maximum Exposure: 421 Days)
NOT COMPLETED
|
0
|
0
|
21
|
22
|
10
|
10
|
Reasons for withdrawal
| Measure |
Run-in Portion: PEGCISGEM
Participants received 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m\^2) of cisplatin (CIS) plus 1000 mg/m\^2 of gemcitabine (GEM) administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Run-in Portion: PEGCISGEMATEZO
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg atezolizumab (ATEZO) (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Expansion Portion: PEGCISGEM
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
|
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Run-in Portion (Max. Exposure: 508 Days)
Investigator or Sponsor Decision
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
Sponsor Terminated Study
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Run-in Portion (Max. Exposure: 508 Days)
Death
|
7
|
3
|
0
|
0
|
0
|
0
|
|
Expansion (Maximum Exposure: 421 Days)
Other than specified
|
0
|
0
|
0
|
3
|
2
|
0
|
|
Expansion (Maximum Exposure: 421 Days)
Investigator or Sponsor Decision
|
0
|
0
|
2
|
1
|
2
|
0
|
|
Expansion (Maximum Exposure: 421 Days)
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
1
|
1
|
|
Expansion (Maximum Exposure: 421 Days)
Sponsor Terminated Study
|
0
|
0
|
7
|
4
|
5
|
3
|
|
Expansion (Maximum Exposure: 421 Days)
Death
|
0
|
0
|
10
|
13
|
0
|
6
|
Baseline Characteristics
Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Run-in Portion: PEGCISGEM
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Run-in Portion: PEGCISGEMATEZO
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Expansion Portion: PEGCISGEM
n=24 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
|
Expansion Portion: PEGCISGEMATEZO Twice Weekly
n=22 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 Participants
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
81 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
50 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)Population: Safety population included all participants who received any study medication.
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Run-in Portion: Number of Participants With Adverse Events (AEs)
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)Population: Safety population included all participants who received any study medication.
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell \[WBC\] count, neutrophils \[ANC\], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen \[BUN\], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], electrolytes \[including sodium, potassium, calcium, magnesium, chloride, and bicarbonate\], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)Population: Data for this outcome measure was not collected due to early termination of study.
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)Population: Safety population included all participants who received any study medication.
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=9 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)Population: Data for this outcome measure was not collected due to early termination of study.
ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)Population: Data for this outcome measure was not Collected due to early termination of study.
ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)Population: Data for this outcome measure was not collected due to early termination of study.
DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)Population: Data for this outcome measure was not collected due to early termination of study.
PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)Population: Data for this outcome measure was not collected due to early termination of study.
DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until death from any cause (maximum exposure: 421 days)Population: This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.
Overall survival was defined as the time from randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until death from any cause (maximum exposure: 421 days)Population: This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.
Overall survival was defined as the time from randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)Population: Safety population included all participants who received any study medication.
An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=22 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=24 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 Participants
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Expansion Portion: Number of Participants With AEs
|
22 Participants
|
24 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)Population: Safety population included all participants who received any study medication.
Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils \[ANC\], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes \[including sodium, potassium, calcium, magnesium, chloride, and bicarbonate\], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=22 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=24 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 Participants
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)Population: Data for this outcome measure was not collected due to early termination of study.
Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)Population: Safety population included all participants who received any study medication.
Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Run-in Portion: PEGCISGEMATEZO
n=22 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Run-in Portion: PEGCISGEM
n=24 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 Participants
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 Participants
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
|
21 Participants
|
16 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9Population: Data for this outcome measure was not collected due to early termination of study.
Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9Population: Data for this outcome measure was not collected due to early termination of study.
PK data were planned to be analyzed using a noncompartmental analysis approach.
Outcome measures
Outcome data not reported
Adverse Events
Run-in Portion: PEGCISGEM
Serious events: 6 serious events
Other events: 9 other events
Deaths: 7 deaths
Run-in Portion: PEGCISGEMATEZO
Serious events: 2 serious events
Other events: 9 other events
Deaths: 3 deaths
Expansion Portion: PEGCISGEM
Serious events: 11 serious events
Other events: 24 other events
Deaths: 10 deaths
Expansion Portion: PEGCISGEMATEZO Twice Weekly
Serious events: 16 serious events
Other events: 22 other events
Deaths: 13 deaths
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Expansion Portion: CISGEM
Serious events: 4 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Run-in Portion: PEGCISGEM
n=9 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Run-in Portion: PEGCISGEMATEZO
n=9 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Expansion Portion: PEGCISGEM
n=24 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
|
Expansion Portion: PEGCISGEMATEZO Twice Weekly
n=22 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 participants at risk
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Asthenia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Chills
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Immune system disorders
Systemic immune activation
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Cholangitis infective
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Sepsis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Reproductive system and breast disorders
Ovarian necrosis
|
0.00%
0/6 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/2 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
7.7%
1/13 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/8 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/6 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/8 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
Other adverse events
| Measure |
Run-in Portion: PEGCISGEM
n=9 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 of CIS plus 1000 mg/m\^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)
|
Run-in Portion: PEGCISGEMATEZO
n=9 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)
|
Expansion Portion: PEGCISGEM
n=24 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).
|
Expansion Portion: PEGCISGEMATEZO Twice Weekly
n=22 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).
|
Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
n=11 participants at risk
Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m\^2 of CIS and 1000 mg/m\^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).
|
Expansion Portion: CISGEM
n=10 participants at risk
Participants received 25 mg/m\^2 CIS and 1000 mg/m\^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
66.7%
6/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
12/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
68.2%
15/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
80.0%
8/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Hypoacusis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Eye disorders
Eye discharge
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Eye disorders
Eye swelling
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Eye disorders
Photopsia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Eye disorders
Visual impairment
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
41.7%
10/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Ascites
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
41.7%
10/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
36.4%
8/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
5/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
37.5%
9/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
40.9%
9/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
12.5%
3/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Enteritis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
75.0%
18/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
11/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
90.0%
9/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
12/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
31.8%
7/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
5/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Asthenia
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Catheter site pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Chest pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Chills
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Fatigue
|
55.6%
5/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
88.9%
8/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
62.5%
15/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
59.1%
13/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
60.0%
6/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Feeling cold
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Injection site bruising
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Injection site pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Localised oedema
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Oedema peripheral
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
55.6%
5/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
41.7%
10/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
45.5%
10/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
30.0%
3/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
25.0%
6/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
11/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
5/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Jaundice
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Candida infection
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
12.5%
3/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
16.7%
4/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
6/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
25.0%
6/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
36.4%
8/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
27.3%
3/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Blood sodium increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Grip strength decreased
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Liver function test increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Monocyte count increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
29.2%
7/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
36.4%
8/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
36.4%
8/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
50.0%
5/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Troponin I increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
Weight increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
40.9%
9/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Investigations
White blood cell count increased
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
44.4%
4/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
25.0%
6/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
40.0%
4/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
12.5%
3/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
30.0%
3/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
37.5%
9/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
31.8%
7/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
30.0%
3/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
45.8%
11/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
36.4%
8/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
8/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
31.8%
7/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
12.5%
3/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.7%
5/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Paraesthesia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
2/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Confusional state
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
16.7%
4/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
33.3%
3/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.8%
5/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
31.8%
7/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/6 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/2 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
7.7%
1/13 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/8 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/6 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/8 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
25.0%
6/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
18.2%
4/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
16.7%
4/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
16.7%
4/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
30.0%
3/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Prurit
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
22.2%
2/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
13.6%
3/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
8.3%
2/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
1/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
20.0%
2/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.2%
1/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
11.1%
1/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
12.5%
3/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
9.1%
2/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
10.0%
1/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/9 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/24 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
4.5%
1/22 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/11 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
0.00%
0/10 • From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
Safety population included all participants who received any study medication.
|
Additional Information
VP, Medical, Regulatory and Drug Safety
Halozyme Therapeutics
Phone: 858-794-8889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60