Trial Outcomes & Findings for A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (NCT NCT05712356)
NCT ID: NCT05712356
Last Updated: 2026-05-26
Results Overview
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
From time of consent until 30 days after treatment discontinuation, up to 18 months
Results posted on
2026-05-26
Participant Flow
Subjects were enrolled from May 2023 to February 2025. All enrolled subjects were from sites in the United States.
Subjects were screened for eligibility within 28 days prior to beginning the study run-in period. Subjects were required to meet all inclusion criteria and none of the exclusion criteria to be eligible for this trial. Screening information, including clinical evaluation, laboratory assessments, tumor biomarkers, imaging, archival tumor tissue if available, and pregnancy test for potential subjects were recorded in the electronic Case Report Form (eCRF), including reasons for ineligibility.
Participant milestones
| Measure |
LSTA1 Arm for Untreated Cholangiocarcinoma
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
|
LSTA1 Arm for Second-Line Cholangiocarcinoma
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
|
Placebo Arm for Untreated Cholangiocarcinoma
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Placebo Arm for Second-Line Cholangiocarcinoma
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
11
|
21
|
11
|
|
Overall Study
COMPLETED
|
23
|
11
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
LSTA1 Arm for Untreated Cholangiocarcinoma
n=23 Participants
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
|
LSTA1 Arm for Second-Line Cholangiocarcinoma
n=11 Participants
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
|
Placebo Arm for Untreated Cholangiocarcinoma
n=21 Participants
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Placebo Arm for Second-Line Cholangiocarcinoma
n=11 Participants
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
6 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
7 Participants
n=50 Participants
|
32 Participants
n=52 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.74 • n=20 Participants
|
62.6 years
STANDARD_DEVIATION 9.99 • n=32 Participants
|
63.5 years
STANDARD_DEVIATION 9.67 • n=64 Participants
|
62.5 years
STANDARD_DEVIATION 8.66 • n=50 Participants
|
62.9 years
STANDARD_DEVIATION 9.52 • n=52 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=20 Participants
|
5 Participants
n=32 Participants
|
12 Participants
n=64 Participants
|
4 Participants
n=50 Participants
|
34 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=50 Participants
|
9 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
9 Participants
n=32 Participants
|
15 Participants
n=64 Participants
|
9 Participants
n=50 Participants
|
52 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
5 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
4 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
8 Participants
n=32 Participants
|
19 Participants
n=64 Participants
|
10 Participants
n=50 Participants
|
56 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=52 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=20 Participants
|
11 participants
n=32 Participants
|
21 participants
n=64 Participants
|
11 participants
n=50 Participants
|
66 participants
n=52 Participants
|
PRIMARY outcome
Timeframe: From time of consent until 30 days after treatment discontinuation, up to 18 monthsThe National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
Outcome measures
| Measure |
LSTA1 Arm for Untreated Cholangiocarcinoma
n=23 Participants
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
|
LSTA1 Arm for Second-Line Cholangiocarcinoma
n=11 Participants
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
|
Placebo Arm for Untreated Cholangiocarcinoma
n=21 Participants
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Placebo Arm for Second-Line Cholangiocarcinoma
n=11 Participants
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
|---|---|---|---|---|
|
Number of Subjects Experiencing Any Adverse Event
|
23 Participants
|
11 Participants
|
21 Participants
|
11 Participants
|
Adverse Events
LSTA1 Arm for Second-Line Cholangiocarcinoma
Serious events: 3 serious events
Other events: 11 other events
Deaths: 4 deaths
LSTA1 Arm for Untreated Cholangiocarcinoma
Serious events: 10 serious events
Other events: 23 other events
Deaths: 12 deaths
Placebo Arm for Untreated Cholangiocarcinoma
Serious events: 12 serious events
Other events: 20 other events
Deaths: 10 deaths
Placebo Arm for Second-Line Cholangiocarcinoma
Serious events: 4 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
LSTA1 Arm for Second-Line Cholangiocarcinoma
n=11 participants at risk
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
|
LSTA1 Arm for Untreated Cholangiocarcinoma
n=23 participants at risk
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
|
Placebo Arm for Untreated Cholangiocarcinoma
n=21 participants at risk
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Placebo Arm for Second-Line Cholangiocarcinoma
n=11 participants at risk
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
COVID-19
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Fatigue
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Embolism
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
Other adverse events
| Measure |
LSTA1 Arm for Second-Line Cholangiocarcinoma
n=11 participants at risk
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
|
LSTA1 Arm for Untreated Cholangiocarcinoma
n=23 participants at risk
certepetide: LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
|
Placebo Arm for Untreated Cholangiocarcinoma
n=21 participants at risk
Durvalumab: 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin: cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine: gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
Placebo Arm for Second-Line Cholangiocarcinoma
n=11 participants at risk
FOLFOX regimen: The following will be given every 14 days:
* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion
* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes
* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)
Placebo: Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Psychiatric disorders
Confusional state
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Chronic kidney disease
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Urinary retention
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Embolism
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Vascular disorders
Deep vein thrombosis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Dry eye
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Eye pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Eye irritation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Eye pruritus
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Surgical and medical procedures
Therapy interrupted
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
47.8%
11/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
57.1%
12/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
45.5%
5/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
26.1%
6/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
52.4%
11/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
30.4%
7/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
26.1%
6/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
23.8%
5/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
21.7%
5/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Tooth discolouration
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Fatigue
|
54.5%
6/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
52.2%
12/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
66.7%
14/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
26.1%
6/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
23.8%
5/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Influenza like illness
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Chest pain
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Chills
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Hernia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Localised oedema
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Malaise
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Mucosal inflammation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Asthenia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Facial pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
General disorders
Temperature intolerance
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Paraesthesia
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Neuropathy peripheral
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Somnolence
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Neutrophil count decreased
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
34.8%
8/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
42.9%
9/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Platelet count decreased
|
45.5%
5/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
30.4%
7/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
White blood cell count decreased
|
36.4%
4/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood creatinine increased
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
28.6%
6/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Lymphocyte count decreased
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Weight increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Haematocrit decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Anaemia
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
43.5%
10/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
42.9%
9/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Decreased appetite
|
63.6%
7/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.3%
3/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
21.7%
5/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
26.1%
6/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
23.8%
5/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
21.7%
5/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
17.4%
4/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
19.0%
4/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Candida infection
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
14.3%
3/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
COVID-19
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Hordeolum
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Tooth infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
13.0%
3/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.5%
2/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
18.2%
2/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
8.7%
2/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.3%
1/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
9.1%
1/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/23 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
4.8%
1/21 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
0.00%
0/11 • Adverse event data were collected from time of consent, up to 18 months, or until patient death
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place