Trial Outcomes & Findings for A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer (NCT NCT02795988)
NCT ID: NCT02795988
Last Updated: 2025-04-16
Results Overview
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Up to approximately 7 months
Results posted on
2025-04-16
Participant Flow
A total of 64 participants were enrolled in the study. Phase 1b, Phase 2, and Phase 2 extension parts enrolled separate participant populations.
Participant milestones
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in intramuscular (IM) injections at a single dose level of 10 micrograms (μg) on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included intravenous (IV) cisplatin and either Fluorouracil (5-FU) infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2: IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2: Chemotherapy Only
Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 100 μg
Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b
STARTED
|
3
|
6
|
5
|
0
|
0
|
0
|
0
|
|
Phase 1b
Received at Least One Dose of Study Drug
|
3
|
6
|
5
|
0
|
0
|
0
|
0
|
|
Phase 1b
COMPLETED
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1b
NOT COMPLETED
|
3
|
5
|
2
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
19
|
17
|
0
|
0
|
|
Phase 2
Received at Least One Dose of Study Drug
|
0
|
0
|
0
|
18
|
14
|
0
|
0
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
19
|
17
|
0
|
0
|
|
Phase 2 Extension
STARTED
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
|
Phase 2 Extension
Received at Least One Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
|
Phase 2 Extension
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Extension
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
Reasons for withdrawal
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in intramuscular (IM) injections at a single dose level of 10 micrograms (μg) on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included intravenous (IV) cisplatin and either Fluorouracil (5-FU) infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2: IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2: Chemotherapy Only
Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 100 μg
Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|---|---|---|
|
Phase 1b
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Death
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1b
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1b
Progressive Disease
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase 2
Death
|
0
|
0
|
0
|
17
|
17
|
0
|
0
|
|
Phase 2
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase 2 Extension
Death
|
0
|
0
|
0
|
0
|
0
|
5
|
6
|
|
Phase 2 Extension
Other reasons
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
Baseline characteristics by cohort
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=3 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=6 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=5 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2: IMU-131 Plus Chemotherapy
n=19 Participants
Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2: Chemotherapy Only
n=17 Participants
Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 100 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Phase 1b
|
51.0 years
STANDARD_DEVIATION 24.6 • n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
60.3 years
STANDARD_DEVIATION 9.8 • n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
57.4 years
STANDARD_DEVIATION 21.0 • n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
57.3 years
STANDARD_DEVIATION 16.7 • n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Age, Continuous
Phase 2
|
—
|
—
|
—
|
64.4 years
STANDARD_DEVIATION 8.53 • n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
64.6 years
STANDARD_DEVIATION 10.31 • n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
64.5 years
STANDARD_DEVIATION 9.28 • n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Age, Continuous
Phase 2 Extension
|
—
|
—
|
—
|
—
|
—
|
62.1 years
STANDARD_DEVIATION 15.19 • n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
69.7 years
STANDARD_DEVIATION 9.25 • n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
65.9 years
STANDARD_DEVIATION 12.71 • n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 1b · Female
|
2 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
2 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
1 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
5 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 1b · Male
|
1 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
4 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
4 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
9 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 2 · Female
|
—
|
—
|
—
|
9 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
4 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
13 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 2 · Male
|
—
|
—
|
—
|
10 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
13 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
23 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 2 Extension · Female
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
2 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
3 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Sex: Female, Male
Phase 2 Extension · Male
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
5 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
11 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 1b · Hispanic or Latino
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 1b · Not Hispanic or Latino
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 1b · Unknown or Not Reported
|
3 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
6 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
5 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
14 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Hispanic or Latino
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
1 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
1 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Not Hispanic or Latino
|
—
|
—
|
—
|
19 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
16 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
35 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 Extension · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 Extension · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
7 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
7 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
14 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Ethnicity (NIH/OMB)
Phase 2 Extension · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · American Indian or Alaska Native
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · Asian
|
3 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
4 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
2 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
9 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · Black or African American
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · White
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
2 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
3 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
5 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · More than one race
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 1b · Unknown or Not Reported
|
0 Participants
n=3 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=6 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=5 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
—
|
—
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · Asian
|
—
|
—
|
—
|
3 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
3 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · Black or African American
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · White
|
—
|
—
|
—
|
16 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
17 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
33 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · More than one race
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 · Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
n=19 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=17 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
—
|
—
|
0 Participants
n=36 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · Asian
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · Black or African American
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · White
|
—
|
—
|
—
|
—
|
—
|
7 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
7 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
14 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · More than one race
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
|
Race (NIH/OMB)
Phase 2 Extension · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=7 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
0 Participants
n=14 Participants • The Phase 1b, Phase 2, and Phase 2 Extension parts enrolled separate participant populations and are reported here separately.
|
PRIMARY outcome
Timeframe: Up to approximately 7 monthsPopulation: The Safety population included all randomized participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=3 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=6 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=5 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants With Adverse Events (AEs)
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 30 monthsPopulation: The Intent-to-Treat population included all randomized participants.
OS was measured from date of randomization to date of death due to any cause.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=19 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=17 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
13.90 months
Interval 7.52 to 14.32
|
8.31 months
Interval 6.01 to 9.59
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of first dose to date of last dose plus 30 days (Up to 24 months)Population: The Safety population included all randomized participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 Extension: Number of Participants With AEs
|
7 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: The ITT Population included all randomized participants.
PFS was measured from randomization to date of earliest progressive disease (PD) based on blinded central review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or to date of death from any cause.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=19 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=17 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Progression-Free Survival (PFS)
|
6.93 months
Interval 5.59 to 9.86
|
6.01 months
Interval 2.17 to 8.31
|
5.03 months
Interval 1.38 to 9.89
|
8.34 months
Interval 5.52 to 8.34
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: The ITT Population included all randomized participants.
TTP was measured from randomization to date of earliest PD based on blinded central review according to RECIST 1.1 criteria.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=19 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=17 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Time to Progression (TTP)
|
6.93 months
Interval 5.59 to 9.86
|
8.44 months
Interval 8.44 to
Upper Confidence Interval (CI) not reached due to insufficient number of events
|
5 months
Interval 4.1 to 8.9
|
5.5 months
Interval 3.5 to 7.5
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: The Full Analysis Set (FAS) included all randomized participants who received any amount of study treatment.
DCR was defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or stable disease according to RECIST 1.1 after randomization/enrollment date.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=18 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=14 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Disease Control Rate (DCR)
|
77.8 percentage of participants
Interval 63.2 to 87.7
|
71.4 percentage of participants
Interval 54.4 to 84.0
|
71.4 percentage of participants
Interval 47.2 to 87.5
|
85.7 percentage of participants
Interval 62.2 to 95.6
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: The FAS included all randomized participants who received any amount of study treatment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
ORR was defined as the proportion of participants with a BOR of CR or PR according RECIST 1.1 after randomization/enrollment date.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=18 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=14 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Objective Response Rate (ORR)
|
38.9 percentage of participants
Interval 25.7 to 53.9
|
50.0 percentage of participants
Interval 33.8 to 66.2
|
42.9 percentage of participants
Interval 22.6 to 65.8
|
71.4 percentage of participants
Interval 47.2 to 87.5
|
SECONDARY outcome
Timeframe: Up to approximately 30 monthsPopulation: All randomized participants with a BOR of CR or PR
DOR was defined as the time from the earliest date when a tumor response of CR or PR was observed until the date of first occurrence of disease progression which assessed by the blinded central reviewer or death (due to any reason).
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=3 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=5 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Duration of Response (DOR)
|
7.10 months
Interval 2.79 to
Upper 80% CI not reached due to insufficient number of events
|
4.40 months
Interval 4.07 to
Upper 80% CI not reached due to insufficient number of events
|
3.65 months
Interval 2.92 to
Upper 80% CI not reached due to insufficient number of events
|
5.59 months
Interval 1.12 to 5.59
|
SECONDARY outcome
Timeframe: Baseline up to approximately 30 monthsPopulation: The ITT Population included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Change in tumor size (CTS) was measured as the sum of diameters based on blinded central review according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=15 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=13 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=6 Participants
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 and Phase 2 Extension: Percentage Change From Baseline in Tumor Size
|
-22.4 percentage change from baseline
Interval -39.4 to -19.7
|
-34.4 percentage change from baseline
Interval -34.6 to -16.9
|
-43.1 percentage change from baseline
Interval -53.7 to -38.0
|
-36.8 percentage change from baseline
Interval -47.7 to -32.2
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: The FAS included all randomized participants who received any amount of study treatment.
OS was measured from date of randomization to date of death due to any cause.
Outcome measures
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=7 Participants
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|
|
Phase 2 Extension: OS
|
18.27 months
Interval 5.03 to 19.84
|
9.36 months
Interval 4.4 to
Upper 80% CI not reached due to insufficient number of events
|
—
|
—
|
Adverse Events
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 2: IMU-131 Plus Chemotherapy
Serious events: 2 serious events
Other events: 18 other events
Deaths: 17 deaths
Phase 2: Chemotherapy Only
Serious events: 5 serious events
Other events: 15 other events
Deaths: 17 deaths
Phase 2 Extension: IMU-131 100 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 2 Extension: IMU-131 200 μg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=3 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=6 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=5 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2: IMU-131 Plus Chemotherapy
n=19 participants at risk
Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2: Chemotherapy Only
n=17 participants at risk
Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 100 μg
n=7 participants at risk
Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 participants at risk
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
Other adverse events
| Measure |
Phase 1b: 10 μg IMU-131 Plus Chemotherapy
n=3 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 10 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 30 μg IMU-131 Plus Chemotherapy
n=6 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 30 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 1b: 50 μg IMU-131 Plus Chemotherapy
n=5 participants at risk
Participants received IMU-131 in IM injections at a single dose level of 50 μg on Days 0, 14, 35, 98 and then every 12 weeks accompanied by chemotherapy every 21 days starting from Day 14. Chemotherapy included IV cisplatin and either 5-FU infusion or oral capecitabine.
|
Phase 2: IMU-131 Plus Chemotherapy
n=19 participants at risk
Participants received IMU-131 in IM injections at dose level of 50 μg on Days 0, 14, 35, 77, and 140, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2: Chemotherapy Only
n=17 participants at risk
Participants received chemotherapy every 21 days for up to 6 cycles starting from Day 14. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 100 μg
n=7 participants at risk
Participants received IMU-131 in IM injections at dose level of 100 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
Phase 2 Extension: IMU-131 200 μg
n=7 participants at risk
Participants received IMU-131 in IM injections at dose level of 200 μg on Days 0, 14, and 35, then every 63 days until disease progression accompanied by chemotherapy every 21 days for up to 6 cycles starting from Day 0. Chemotherapy included one of the following treatments:
* IV cisplatin and either 5-FU infusion or oral capecitabine.
* IV oxaliplatin and oral capecitabine.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Up to approximately 30 months
|
83.3%
5/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
15.8%
3/19 • Up to approximately 30 months
|
29.4%
5/17 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to approximately 30 months
|
50.0%
3/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
11.8%
2/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
40.0%
2/5 • Up to approximately 30 months
|
26.3%
5/19 • Up to approximately 30 months
|
17.6%
3/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
60.0%
3/5 • Up to approximately 30 months
|
21.1%
4/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
15.8%
3/19 • Up to approximately 30 months
|
17.6%
3/17 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
|
General disorders
Chest pain
|
33.3%
1/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to approximately 30 months
|
50.0%
3/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
26.3%
5/19 • Up to approximately 30 months
|
11.8%
2/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
42.9%
3/7 • Up to approximately 30 months
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
General disorders
Oedema
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Gallbladder polyp
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Hepatobiliary disorders
Liver disorder
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Administration site infection
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Clostridium difficile colitis
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
40.0%
2/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Ejection fraction decreased
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
10.5%
2/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
23.5%
4/17 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Protein total increased
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Prothrombin time prolonged
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
10.5%
2/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 30 months
|
50.0%
3/6 • Up to approximately 30 months
|
40.0%
2/5 • Up to approximately 30 months
|
26.3%
5/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
33.3%
1/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • Up to approximately 30 months
|
66.7%
4/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
11.8%
2/17 • Up to approximately 30 months
|
28.6%
2/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to approximately 30 months
|
50.0%
3/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
40.0%
2/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
40.0%
2/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Renal and urinary disorders
Renal failure
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 30 months
|
33.3%
2/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
1/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
20.0%
1/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to approximately 30 months
|
16.7%
1/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
10.5%
2/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
10.5%
2/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Extravasation
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Vaccination site pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Chills
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
26.3%
5/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
11.8%
2/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
11.8%
2/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
10.5%
2/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
5.9%
1/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
5.3%
1/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
|
General disorders
Infusion site pain
|
0.00%
0/3 • Up to approximately 30 months
|
0.00%
0/6 • Up to approximately 30 months
|
0.00%
0/5 • Up to approximately 30 months
|
0.00%
0/19 • Up to approximately 30 months
|
0.00%
0/17 • Up to approximately 30 months
|
0.00%
0/7 • Up to approximately 30 months
|
14.3%
1/7 • Up to approximately 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place