Trial Outcomes & Findings for A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (NCT NCT04083235)
NCT ID: NCT04083235
Last Updated: 2026-04-20
Results Overview
The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
770 participants
Primary outcome timeframe
Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)
Results posted on
2026-04-20
Participant Flow
This Phase 3, open-label study was conducted in participants with metastatic adenocarcinoma of the pancreas at 187 investigational sites in 18 countries (Australia, Brazil, Canada, Israel, Republic of Korea, United States, Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Portugal, Spain, United Kingdom, and Russia) between 11 February 2020 and 18 February 2025.
This study consisted of a screening period (up to 28 days), treatment period (28-day cycles of treatment until radiologically determined disease progression per response evaluation criteria in solid tumors \[RECIST 1.1\]), unacceptable study medication related toxicity or withdrawal from study treatment followed by survival follow-up (until death or study closure, whichever occurred first). A total of 770 participants were randomized in 1:1 ratio using an interactive web response system (IWRS).
Participant milestones
| Measure |
NALIRIFOX
Participants were treated with irinotecan liposome injection 50 milligram per square meter (mg/m\^2) followed by oxaliplatin 60 mg/m\^2, followed by leucovorin (LV) 400 mg/m\^2 and then 5-fluorouracil (FU) 2400 mg/m\^2 intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
383
|
387
|
|
Overall Study
Received Treatment
|
370
|
379
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
383
|
387
|
Reasons for withdrawal
| Measure |
NALIRIFOX
Participants were treated with irinotecan liposome injection 50 milligram per square meter (mg/m\^2) followed by oxaliplatin 60 mg/m\^2, followed by leucovorin (LV) 400 mg/m\^2 and then 5-fluorouracil (FU) 2400 mg/m\^2 intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Death
|
338
|
351
|
|
Overall Study
Withdrawal by Subject
|
18
|
20
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Progressive disease per RECIST
|
9
|
5
|
|
Overall Study
Adverse Event
|
5
|
8
|
|
Overall Study
Switched to commercial drug supply
|
5
|
0
|
|
Overall Study
Transition to expanded access program
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Participant randomized in error
|
0
|
1
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Does Not Meet Entry Criteria
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Baseline characteristics by cohort
| Measure |
NALIRIFOX
n=383 Participants
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=387 Participants
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Total
n=770 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 9.71 • n=129 Participants
|
64.0 years
STANDARD_DEVIATION 8.34 • n=22 Participants
|
63.4 years
STANDARD_DEVIATION 9.06 • n=151 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=129 Participants
|
157 Participants
n=22 Participants
|
336 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=129 Participants
|
230 Participants
n=22 Participants
|
434 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=129 Participants
|
30 Participants
n=22 Participants
|
79 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
305 Participants
n=129 Participants
|
328 Participants
n=22 Participants
|
633 Participants
n=151 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=129 Participants
|
29 Participants
n=22 Participants
|
58 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
White
|
315 Participants
n=129 Participants
|
324 Participants
n=22 Participants
|
639 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
26 Participants
n=129 Participants
|
29 Participants
n=22 Participants
|
55 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=129 Participants
|
18 Participants
n=22 Participants
|
38 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=129 Participants
|
7 Participants
n=22 Participants
|
19 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=129 Participants
|
6 Participants
n=22 Participants
|
13 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
3 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=151 Participants
|
PRIMARY outcome
Timeframe: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)Population: The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
The OS was defined as time from the date of randomization to the date of death due to any cause. Participants who did not have a date of death recorded at the time of the final analysis were censored at the last known time that the participant was alive. The median OS was measured using Kaplan-Meier technique.
Outcome measures
| Measure |
NALIRIFOX
n=383 Participants
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=387 Participants
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
11.1 months
Interval 10.0 to 12.1
|
9.2 months
Interval 8.3 to 10.6
|
SECONDARY outcome
Timeframe: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022 (maximum of 893 days)Population: The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization. Only participants with PFS event are reported.
PFS was defined as the time from the date of randomization to the first documented disease progression using response evaluation criteria in solid tumors (RECIST) Version 1.1 as per Investigator assessment or death due to any cause. The median PFS was measured using Kaplan-Meier technique.
Outcome measures
| Measure |
NALIRIFOX
n=249 Participants
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=259 Participants
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
7.4 months
Interval 6.0 to 7.7
|
5.6 months
Interval 5.3 to 5.8
|
SECONDARY outcome
Timeframe: Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose up to PCD of 23 July 2022, (maximum of 893 days)Population: The ITT population consisted of all randomized participants to whom study treatment was assigned by randomization.
The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) per RECIST Version 1.1. BOR was defined as the best response as recorded from randomization until documented objective disease progression using RECIST Version 1.1. As per RECIST version 1.1, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. The ORR was calculated using Clopper-Pearson method.
Outcome measures
| Measure |
NALIRIFOX
n=383 Participants
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=387 Participants
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
41.8 percentage of participants
Interval 36.8 to 46.9
|
36.2 percentage of participants
Interval 31.4 to 41.2
|
Adverse Events
NALIRIFOX
Serious events: 207 serious events
Other events: 364 other events
Deaths: 345 deaths
Nab-paclitaxel+Gemcitabine
Serious events: 198 serious events
Other events: 371 other events
Deaths: 359 deaths
Serious adverse events
| Measure |
NALIRIFOX
n=370 participants at risk
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=379 participants at risk
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
23/370 • Number of events 28 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
2.4%
9/379 • Number of events 9 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
22/370 • Number of events 27 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.6%
6/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
18/370 • Number of events 25 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
9/370 • Number of events 11 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
2.1%
8/379 • Number of events 8 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
COVID-19
|
4.9%
18/370 • Number of events 18 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.5%
17/379 • Number of events 17 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Pneumonia
|
1.9%
7/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.4%
13/379 • Number of events 13 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Pyrexia
|
2.4%
9/370 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.2%
12/379 • Number of events 14 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
10/370 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.8%
7/379 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
6/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
2.1%
8/379 • Number of events 8 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
4/370 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
2.1%
8/379 • Number of events 8 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
6/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.3%
5/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Colitis
|
1.9%
7/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Constipation
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.6%
6/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.81%
3/370 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
4/370 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Ileus
|
0.81%
3/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.54%
2/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.81%
3/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Haematemesis
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.54%
2/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Sepsis
|
1.6%
6/370 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.2%
16/379 • Number of events 18 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Urinary tract infection
|
0.81%
3/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Biliary tract infection
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Febrile infection
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Gastroenteritis
|
0.81%
3/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Bacteraemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Diverticulitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Erysipelas
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Septic shock
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Anal abscess
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Atypical pneumonia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Campylobacter colitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Device related infection
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Gallbladder abscess
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Hepatitis E
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Implant site cellulitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Large intestine infection
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Liver abscess
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Streptococcal infection
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Asthenia
|
1.9%
7/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Fatigue
|
1.9%
7/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
General physical health deterioration
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.6%
6/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Malaise
|
0.81%
3/370 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Oedema peripheral
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Mucosal inflammation
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Peripheral swelling
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Chest pain
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Condition aggravated
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Generalised oedema
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Inadequate analgesia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Inflammation
|
0.27%
1/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Pain
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Performance status decreased
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Sudden cardiac death
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Sudden death
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
11/370 • Number of events 12 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
6/370 • Number of events 7 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
5/370 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.3%
5/379 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
8/370 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.6%
6/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Hypotension
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Embolism
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Peripheral ischaemia
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Embolism arterial
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Hypertension
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Iliac vein occlusion
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Peripheral embolism
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Cholangitis
|
1.4%
5/370 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.6%
6/379 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Biliary obstruction
|
1.6%
6/370 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Cholestasis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
4/370 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
4/370 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Aphasia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Pineal gland cyst
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Seizure
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Tremor
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Blood bilirubin increased
|
1.4%
5/370 • Number of events 5 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Neutrophil count decreased
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
SARS-CoV-2 test positive
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
White blood cell count decreased
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Blood glucose abnormal
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
General physical condition abnormal
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Haemoglobin decreased
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Platelet count decreased
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.81%
3/370 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
2.4%
9/379 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Renal impairment
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Renal failure
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.79%
3/379 • Number of events 3 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Cardiac arrest
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Angina pectoris
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Atrial flutter
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Exposure to SARS-CoV-2
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
1.1%
4/379 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Confusional state
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Mental status changes
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Delirium
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Depression
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.53%
2/379 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
2/370 • Number of events 2 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Reproductive system and breast disorders
Penile vein thrombosis
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Reproductive system and breast disorders
Priapism
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Eye disorders
Retinal vein occlusion
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Product Issues
Thrombosis in device
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Gastric varices
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.27%
1/370 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.00%
0/379 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/370 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
0.26%
1/379 • Number of events 1 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
Other adverse events
| Measure |
NALIRIFOX
n=370 participants at risk
Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Nab-paclitaxel+Gemcitabine
n=379 participants at risk
Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
69.5%
257/370 • Number of events 580 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
35.9%
136/379 • Number of events 221 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Nausea
|
58.4%
216/370 • Number of events 417 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
42.5%
161/379 • Number of events 219 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Vomiting
|
37.8%
140/370 • Number of events 227 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
25.1%
95/379 • Number of events 169 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Stomatitis
|
14.6%
54/370 • Number of events 94 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
11.9%
45/379 • Number of events 54 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Constipation
|
25.9%
96/370 • Number of events 119 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
29.3%
111/379 • Number of events 140 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
24.9%
92/370 • Number of events 112 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
19.0%
72/379 • Number of events 80 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
29/370 • Number of events 30 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.7%
14/379 • Number of events 16 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Fatigue
|
32.7%
121/370 • Number of events 181 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
37.7%
143/379 • Number of events 183 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Asthenia
|
30.0%
111/370 • Number of events 173 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
27.2%
103/379 • Number of events 170 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Oedema peripheral
|
14.3%
53/370 • Number of events 61 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
28.5%
108/379 • Number of events 135 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Mucosal inflammation
|
14.3%
53/370 • Number of events 69 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.2%
16/379 • Number of events 20 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Pyrexia
|
10.0%
37/370 • Number of events 48 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
21.6%
82/379 • Number of events 131 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Neuropathy peripheral
|
18.9%
70/370 • Number of events 94 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
17.9%
68/379 • Number of events 94 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Dysgeusia
|
17.0%
63/370 • Number of events 76 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
15.3%
58/379 • Number of events 68 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.1%
56/370 • Number of events 88 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
13.5%
51/379 • Number of events 60 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Paraesthesia
|
11.9%
44/370 • Number of events 53 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.7%
33/379 • Number of events 41 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.9%
107/370 • Number of events 298 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
31.9%
121/379 • Number of events 280 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.2%
97/370 • Number of events 151 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
40.4%
153/379 • Number of events 199 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.8%
51/370 • Number of events 105 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
22.2%
84/379 • Number of events 176 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.4%
20/370 • Number of events 71 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.3%
24/379 • Number of events 43 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Neutrophil count decreased
|
20.3%
75/370 • Number of events 227 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
18.2%
69/379 • Number of events 132 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Platelet count decreased
|
11.4%
42/370 • Number of events 98 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
17.9%
68/379 • Number of events 113 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Weight decreased
|
22.2%
82/370 • Number of events 92 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.7%
33/379 • Number of events 34 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Alanine aminotransferase increased
|
12.4%
46/370 • Number of events 69 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
12.7%
48/379 • Number of events 64 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
42/370 • Number of events 63 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
10.6%
40/379 • Number of events 55 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
White blood cell count decreased
|
4.3%
16/370 • Number of events 26 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.7%
33/379 • Number of events 56 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.8%
136/370 • Number of events 165 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
27.4%
104/379 • Number of events 138 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.4%
116/370 • Number of events 205 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
13.2%
50/379 • Number of events 72 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.7%
36/370 • Number of events 41 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
7.7%
29/379 • Number of events 31 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
53/370 • Number of events 54 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
31.4%
119/379 • Number of events 120 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
11/370 • Number of events 12 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
9.0%
34/379 • Number of events 37 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.1%
4/370 • Number of events 4 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.6%
25/379 • Number of events 30 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
16/370 • Number of events 17 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
11.3%
43/379 • Number of events 49 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
14/370 • Number of events 16 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.7%
33/379 • Number of events 46 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
29/370 • Number of events 37 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.5%
21/379 • Number of events 29 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
30/370 • Number of events 33 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.7%
18/379 • Number of events 21 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
25/370 • Number of events 34 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.7%
18/379 • Number of events 20 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
24/370 • Number of events 29 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.7%
14/379 • Number of events 16 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.4%
20/370 • Number of events 23 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.2%
12/379 • Number of events 13 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
General disorders
Chills
|
1.6%
6/370 • Number of events 6 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.0%
19/379 • Number of events 20 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Dizziness
|
7.0%
26/370 • Number of events 28 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
10.6%
40/379 • Number of events 44 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Headache
|
6.2%
23/370 • Number of events 37 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.3%
20/379 • Number of events 25 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Nervous system disorders
Neurotoxicity
|
5.9%
22/370 • Number of events 36 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
3.4%
13/379 • Number of events 22 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.3%
27/370 • Number of events 34 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
7.9%
30/379 • Number of events 31 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.7%
36/370 • Number of events 47 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.2%
16/379 • Number of events 21 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.1%
19/370 • Number of events 22 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.7%
18/379 • Number of events 21 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.9%
44/370 • Number of events 52 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
9.0%
34/379 • Number of events 35 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
37/370 • Number of events 43 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.2%
31/379 • Number of events 33 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Investigations
Blood bilirubin increased
|
5.4%
20/370 • Number of events 24 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.8%
22/379 • Number of events 23 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
12/370 • Number of events 14 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.8%
22/379 • Number of events 26 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Infections and infestations
Urinary tract infection
|
7.6%
28/370 • Number of events 30 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.1%
23/379 • Number of events 29 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
26/370 • Number of events 33 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
11.9%
45/379 • Number of events 48 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.7%
21/370 • Number of events 21 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.3%
24/379 • Number of events 24 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
17/370 • Number of events 24 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
7.9%
30/379 • Number of events 31 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
31/370 • Number of events 43 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.7%
33/379 • Number of events 36 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
16/370 • Number of events 19 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.4%
32/379 • Number of events 43 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.6%
17/370 • Number of events 22 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
5.5%
21/379 • Number of events 24 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
9/370 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
7.9%
30/379 • Number of events 35 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Hypotension
|
5.7%
21/370 • Number of events 27 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.6%
25/379 • Number of events 26 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Vascular disorders
Hypertension
|
6.2%
23/370 • Number of events 26 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
4.0%
15/379 • Number of events 19 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Insomnia
|
7.8%
29/370 • Number of events 29 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
8.4%
32/379 • Number of events 32 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
|
Psychiatric disorders
Anxiety
|
2.7%
10/370 • Number of events 10 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
6.3%
24/379 • Number of events 25 • Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
The Safety population was a subset of the ITT population that received at least 1 dose (including a partial dose) of any component of the study medication in the combination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER