Trial Outcomes & Findings for A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer (NCT NCT01373164)
NCT ID: NCT01373164
Last Updated: 2018-05-16
Results Overview
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Time of first phase 1b dose until time of last phase 1b dose (up to 1 year)
Results posted on
2018-05-16
Participant Flow
Completers included participants who died from any cause and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
Participant milestones
| Measure |
Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 160 mg Galunisertib + Gemcitabine
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: 300 mg Galunisertib + Gemcitabine
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: Placebo + Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
104
|
52
|
|
Overall Study
Received at Least One Dose
|
5
|
4
|
5
|
103
|
52
|
|
Overall Study
COMPLETED
|
5
|
3
|
4
|
92
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
12
|
2
|
Reasons for withdrawal
| Measure |
Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 (milligrams per square meter) was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 160 mg Galunisertib + Gemcitabine
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: 300 mg Galunisertib + Gemcitabine
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: Placebo + Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
10
|
2
|
Baseline Characteristics
A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b: 80 mg Galunisertib + Gemcitabine
n=5 Participants
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 160 mg Galunisertib + Gemcitabine
n=4 Participants
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=5 Participants
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: 300 mg Galunisertib + Gemcitabine
n=103 Participants
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: Placebo + Gemcitabine
n=52 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. participants may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
56.6 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
67.3 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
66.3 Years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
63.5 Years
STANDARD_DEVIATION 9.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
76 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
93 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
100 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
157 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Time of first phase 1b dose until time of last phase 1b dose (up to 1 year)Population: Phase 1b: All participants who received at least one dose of study drug.
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.
Outcome measures
| Measure |
Phase 1b Participants
n=14 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 1b: Recommended Phase 2 Dose
|
300 milligrams (mg)
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to date of death from any cause (up to 2 years)Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 20 and Placebo + Gemcitabine = 4.
Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Outcome measures
| Measure |
Phase 1b Participants
n=104 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=52 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
8.9 Months
Interval 7.3 to 11.1
|
7.1 Months
Interval 5.8 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)Population: Phase 1b: All participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.
AUC\[0-24h\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.
Outcome measures
| Measure |
Phase 1b Participants
n=3 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=2 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=3 Participants
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)
AUC(0-24)
|
2530 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 116
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants with enough PK samples.
|
9090 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
|
Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)
AUC(0-∞)
|
2740 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 117
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants with enough PK samples.
|
10600 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 10
|
SECONDARY outcome
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)Population: Phase 1b: All participants who received at least one dose of study drug and had evaluable PK data.
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
Outcome measures
| Measure |
Phase 1b Participants
n=3 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=2 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=3 Participants
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)
|
385 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 101
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants with enough PK samples.
|
1050 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
SECONDARY outcome
Timeframe: Baseline to end of Phase 1b (up to 1 year)Population: Phase 1b: All participants who received at least one dose of study drug.
Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Outcome measures
| Measure |
Phase 1b Participants
n=5 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=4 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=5 Participants
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Tumor Response
Progressive Disease (PD)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Phase 1b: Number of Participants With Tumor Response
Stable Disease (SD)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Phase 1b: Number of Participants With Tumor Response
Partial Response (PR)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Tumor Response
Non-Complete Response/Non-Progressive Disease (NC)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Tumor Response
Not Assessed (NA)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to first date of progressive disease or death due to any cause (up to 2 years)Population: All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 21 and Placebo + Gemcitabine = 11.
PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Phase 1b Participants
n=104 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=52 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
|
4.11 Months
Interval 2.66 to 5.42
|
2.86 Months
Interval 1.94 to 3.75
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of Cycle 2 (up to 56 days)Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for change in tumor size.
Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.
Outcome measures
| Measure |
Phase 1b Participants
n=104 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=52 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Percentage Change From Baseline in Tumor Size (CTS)
Independent Assessor 1
|
0.95 Percent change in tumor size
Interval 0.9 to 1.01
|
0.92 Percent change in tumor size
Interval 0.87 to 0.98
|
—
|
|
Phase 2: Percentage Change From Baseline in Tumor Size (CTS)
Independent Assessor 2
|
1.03 Percent change in tumor size
Interval 0.95 to 1.11
|
0.98 Percent change in tumor size
Interval 0.92 to 1.05
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease (up to 2 years)Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for ORR.
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Outcome measures
| Measure |
Phase 1b Participants
n=104 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=52 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
|
10.6 Percentage of Participants
Interval 5.4 to 18.1
|
3.8 Percentage of Participants
Interval 0.5 to 13.2
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)Population: All randomized participants who received at least 1 dose of study drug with evaluable PK data.
AUC\[0-24\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.
Outcome measures
| Measure |
Phase 1b Participants
n=99 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])
|
5.56 mg*h/L
Interval 3.82 to 7.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)Population: All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
Outcome measures
| Measure |
Phase 1b Participants
n=99 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib
|
904 ng/mL
Interval 668.0 to 1194.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, study treatment completion (up to 1 year)Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BPI-sf.
The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.
Outcome measures
| Measure |
Phase 1b Participants
n=7 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=2 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion
|
2.54 Units on a scale
Standard Deviation 2.53
|
1.50 Units on a scale
Standard Deviation 2.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, study treatment completion after first follow up visit (up to 1 year)Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for CA19-9 level.
Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up
Outcome measures
| Measure |
Phase 1b Participants
n=38 Participants
Participants received galunisertib at a starting dose of 80 mg/day in combination with gemcitabine. Dose escalation proceeded in cohorts of between 3 to 6 evaluable participants until ≥2 participants experienced a dose limiting toxicity (DLT) or an galunisertib dose level of 300 mg/day was reached.
|
Phase 2: Placebo + Gemcitabine
n=21 Participants
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks. Participant's may continue until disease progression, unacceptable toxicity, or another withdrawal criterion is met.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|
|
Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up
|
32.7 Units/Milliliter (U/mL)
Interval -93.8 to 3636.3
|
-33.3 Units/Milliliter (U/mL)
Interval -98.1 to 2460.9
|
—
|
Adverse Events
Phase 1b: 80 mg Galunisertib + Gemcitabine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b: 160 mg Galunisertib + Gemcitabine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1b: 300 mg Galunisertib + Gemcitabine
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 2: 300 mg Galunisertib + Gemcitabine
Serious events: 56 serious events
Other events: 100 other events
Deaths: 0 deaths
Phase 2: Placebo + Gemcitabine
Serious events: 26 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b: 80 mg Galunisertib + Gemcitabine
n=5 participants at risk
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 160 mg Galunisertib + Gemcitabine
n=4 participants at risk
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=5 participants at risk
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: 300 mg Galunisertib + Gemcitabine
n=103 participants at risk
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: Placebo + Gemcitabine
n=52 participants at risk
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Multi-organ failure
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Pancreatic pseudocyst drainage
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Phase 1b: 80 mg Galunisertib + Gemcitabine
n=5 participants at risk
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 160 mg Galunisertib + Gemcitabine
n=4 participants at risk
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 1b: 300 mg Galunisertib + Gemcitabine
n=5 participants at risk
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: 300 mg Galunisertib + Gemcitabine
n=103 participants at risk
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
Phase 2: Placebo + Gemcitabine
n=52 participants at risk
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle).
Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
75.0%
3/4 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
60.0%
3/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
42.7%
44/103 • Number of events 95 • Up to 30 days
All participants who received at least one dose of study drug.
|
53.8%
28/52 • Number of events 35 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
33.0%
34/103 • Number of events 76 • Up to 30 days
All participants who received at least one dose of study drug.
|
32.7%
17/52 • Number of events 42 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
4/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
28.2%
29/103 • Number of events 83 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
13/52 • Number of events 21 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.2%
26/103 • Number of events 38 • Up to 30 days
All participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 16 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
11.7%
12/103 • Number of events 16 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
12.6%
13/103 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
29.1%
30/103 • Number of events 31 • Up to 30 days
All participants who received at least one dose of study drug.
|
28.8%
15/52 • Number of events 22 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
22.3%
23/103 • Number of events 56 • Up to 30 days
All participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 26 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.8%
8/103 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
100.0%
4/4 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
80.0%
4/5 • Number of events 9 • Up to 30 days
All participants who received at least one dose of study drug.
|
37.9%
39/103 • Number of events 69 • Up to 30 days
All participants who received at least one dose of study drug.
|
32.7%
17/52 • Number of events 30 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
20.0%
1/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
75.0%
3/4 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
60.0%
3/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
26.2%
27/103 • Number of events 57 • Up to 30 days
All participants who received at least one dose of study drug.
|
36.5%
19/52 • Number of events 26 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
60.0%
3/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
35.0%
36/103 • Number of events 72 • Up to 30 days
All participants who received at least one dose of study drug.
|
32.7%
17/52 • Number of events 30 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.7%
10/103 • Number of events 12 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.4%
21/103 • Number of events 28 • Up to 30 days
All participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Localised oedema
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
22.3%
23/103 • Number of events 33 • Up to 30 days
All participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 15 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
75.0%
3/4 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
36.9%
38/103 • Number of events 93 • Up to 30 days
All participants who received at least one dose of study drug.
|
21.2%
11/52 • Number of events 17 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
6.8%
7/103 • Number of events 9 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.7%
10/103 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.8%
8/103 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.8%
8/103 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood calcium decreased
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood sodium decreased
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
10.7%
11/103 • Number of events 31 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 10 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
16.5%
17/103 • Number of events 38 • Up to 30 days
All participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
8.7%
9/103 • Number of events 16 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
29.1%
30/103 • Number of events 42 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
13/52 • Number of events 18 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.8%
8/103 • Number of events 14 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
12.6%
13/103 • Number of events 17 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
2.9%
3/103 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.8%
8/103 • Number of events 9 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 3 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 8 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.9%
4/103 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
40.0%
2/5 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.97%
1/103 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
6.8%
7/103 • Number of events 10 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
5.8%
6/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/103 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
1.9%
2/103 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up to 30 days
All participants who received at least one dose of study drug.
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 6 • Up to 30 days
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Up to 30 days
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up to 30 days
All participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up to 30 days
All participants who received at least one dose of study drug.
|
4.9%
5/103 • Number of events 7 • Up to 30 days
All participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 9 • Up to 30 days
All participants who received at least one dose of study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60