Trial Outcomes & Findings for ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma (NCT NCT04245085)
NCT ID: NCT04245085
Last Updated: 2026-05-12
Results Overview
Progression-Free Survival (PFS) rate at 12-months is defined as the rate of patients without a PFS event at 12 months from randomisation. PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
From randomization to 12 months; participants assessed for progression-free survival status at 12 months.
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
Arm A
* Atezolizumab (1200 mg) Q3W, until PD\*
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
* Atezolizumab treatment beyond RECIST v.1.1-defined progression will be allowed if patient is continuing to derive clinical benefit.
|
Arm B
* Atezolizumab (1200 mg), Q3W, until PD\*
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
* Atezolizumab treatment beyond RECIST v.1.1-defined progression will be allowed if patient is continuing to derive clinical benefit.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
50
|
|
Overall Study
Received at list one dose of trial treatment
|
44
|
50
|
|
Overall Study
On treatment
|
3
|
3
|
|
Overall Study
Treatment failures
|
42
|
47
|
|
Overall Study
Never started treatment
|
0
|
1
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
Reasons for withdrawal
| Measure |
Arm A
* Atezolizumab (1200 mg) Q3W, until PD\*
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
* Atezolizumab treatment beyond RECIST v.1.1-defined progression will be allowed if patient is continuing to derive clinical benefit.
|
Arm B
* Atezolizumab (1200 mg), Q3W, until PD\*
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
* Atezolizumab treatment beyond RECIST v.1.1-defined progression will be allowed if patient is continuing to derive clinical benefit.
|
|---|---|---|
|
Overall Study
Death
|
26
|
27
|
|
Overall Study
Withdrawal/Lost to follow-up
|
3
|
3
|
Baseline Characteristics
ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma
Baseline characteristics by cohort
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Prior TKI treatment
Osimertinib or Savolitinib
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Age, Continuous
|
61 years
n=1512 Participants
|
63 years
n=504 Participants
|
62 years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=1512 Participants
|
33 Participants
n=504 Participants
|
60 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=1512 Participants
|
17 Participants
n=504 Participants
|
35 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
52 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=1512 Participants
|
21 Participants
n=504 Participants
|
41 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
ECOG Performance Status
0
|
16 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
24 Participants
n=2016 Participants
|
|
ECOG Performance Status
1
|
29 Participants
n=1512 Participants
|
42 Participants
n=504 Participants
|
71 Participants
n=2016 Participants
|
|
Smoking status
Current smoker
|
3 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
|
Smoking status
Former smoker
|
17 Participants
n=1512 Participants
|
14 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
|
Smoking status
Never smoked
|
25 Participants
n=1512 Participants
|
32 Participants
n=504 Participants
|
57 Participants
n=2016 Participants
|
|
Stage
IIIB
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Stage
IVA
|
10 Participants
n=1512 Participants
|
21 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
|
Stage
IVB
|
34 Participants
n=1512 Participants
|
29 Participants
n=504 Participants
|
63 Participants
n=2016 Participants
|
|
Brain metastasis
Yes
|
15 Participants
n=1512 Participants
|
16 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
|
EGFR mutation type
Exon 19 deletion
|
28 Participants
n=1512 Participants
|
29 Participants
n=504 Participants
|
57 Participants
n=2016 Participants
|
|
EGFR mutation type
Exon 21 L858R
|
16 Participants
n=1512 Participants
|
19 Participants
n=504 Participants
|
35 Participants
n=2016 Participants
|
|
EGFR mutation type
Other
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Prior TKI treatment
Afatinib
|
9 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
17 Participants
n=2016 Participants
|
|
Prior TKI treatment
Erlotinib
|
2 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Prior TKI treatment
Gefitinib
|
4 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
|
Prior TKI treatment
Lazertinib
|
1 Participants
n=1512 Participants
|
5 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Prior TKI treatment
Nazartinib
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Prior TKI treatment
Osimertinib
|
28 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
55 Participants
n=2016 Participants
|
|
Prior TKI treatment
Osimertinib or Lazertinib
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Brain metastasis
No
|
30 Participants
n=1512 Participants
|
34 Participants
n=504 Participants
|
64 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: From randomization to 12 months; participants assessed for progression-free survival status at 12 months.Population: Primary efficacy cohort (randomized patients who are not lost from follow-up before a PFS event or earlier than one-year of follow-up)
Progression-Free Survival (PFS) rate at 12-months is defined as the rate of patients without a PFS event at 12 months from randomisation. PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
Outcome measures
| Measure |
Arm A
n=43 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=45 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Progression-Free Survival (PFS) Rate at 12-months
|
9 Participants
Interval 10.0 to 36.0
|
11 Participants
Interval 12.9 to 39.5
|
SECONDARY outcome
Timeframe: From randomization until documented progression (PD) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.Population: Intention-To-Treat cohort of all randomised patients
PFS is defined as the time from the date of randomisation until documented progression (according to RECIST v1.1) or death, if progression is not documented. Censoring (for patients without a PFS/death event) will occur at the last tumour assessment if the patient is lost to follow-up or refuses further documentation of follow-up.
Outcome measures
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Progression-Free Survival
|
6.4 months
Interval 5.3 to 8.3
|
7.6 months
Interval 4.1 to 9.7
|
SECONDARY outcome
Timeframe: Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.Population: Safety population (all patients who received at least 1 dose of trial treatment): 44 in arm A/50 in arm B. Of note, in the next section, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B), while serious adverse events/adverse events were assessed for the safety population.
Adverse events, graded by CTCAE version 5.0.
Outcome measures
| Measure |
Arm A
n=44 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Adverse Events
Experienced AE/SAE
|
43 Participants
|
49 Participants
|
|
Adverse Events
No AE/SAE
|
1 Participants
|
1 Participants
|
|
Adverse Events
Experienced SAE
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From randomization until death from any cause, up to 3 years.Population: Intention-To-Treat cohort of all randomised patients
OS is defined as the time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.
Outcome measures
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Overall Survival
|
15.4 months
Interval 9.4 to 23.9
|
15.6 months
Interval 11.8 to
Upper limit is not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomisation to termination of trial treatment, up to 3 years.Population: Intention-To-Treat cohort of all randomised patients
Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST v1.1, from randomisation until either the end of protocol treatment or the end of follow-up.
Outcome measures
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Objective Response
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From randomization until patient deterioration status (score for QLQ-C30 global health status/QoL scale shows a ≥10-point decrease from baseline), up to 3 years.Population: QoL cohort (patients who received at least 1 dose of trial treatment, with baseline QoL assessment and post-baseline QoL forms)
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point decrease above baseline in the EORTC-QLQ-C30 global health/ QoL scale. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment. Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Outcome measures
| Measure |
Arm A
n=40 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=48 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Time to Deterioration (TTDet) in the QLQ-C30 Global Health Status/Global QoL Scale
|
7.2 months
Interval 2.7 to
Upper limit is not determined as there was an insufficient number of participants with events.
|
NA months
Interval 3.5 to
Median deterioration time and upper limit are not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization until patient deterioration status (score for QLQ-LC13 'Cough' symptom shows a ≥10-point increase from baseline), up to 3 years.Population: QoL cohort (patients who received at least 1 dose of trial treatment, with available Coughing QLQ-LC13 score at baseline and post-baseline)
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Cough' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment. Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Outcome measures
| Measure |
Arm A
n=40 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=48 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Time to Deterioration (TTDet) in the QLQ-LC13 'Cough' Symptom
|
NA months
Interval 8.6 to
Median deterioration time and upper limit are not determined as there was an insufficient number of participants with events.
|
NA months
Median deterioration time, lower and upper limit are not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization until patient deterioration status (score for QLQ-LC13 'Dyspnoea' symptom shows a ≥10-point increase from baseline), up to 3 years.Population: QoL cohort (patients who received at least 1 dose of trial treatment, with available Dyspnoea QLQ-LC13 score at baseline and post-baseline)
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Dyspnoea' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment. Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Outcome measures
| Measure |
Arm A
n=40 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=47 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Time to Deterioration (TTDet) in the QLQ-LC13 'Dyspnoea' Symptom
|
NA months
Interval 4.2 to
Median deterioration time and upper limit are not determined as there was an insufficient number of participants with events.
|
10.2 months
Interval 2.7 to
Upper limit of median deterioration time is not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization until patient deterioration status (score for QLQ-LC13 'Chest pain' symptom shows a ≥10-point increase from baseline), up to 3 years.Population: QoL cohort (patients who received at least 1 dose of trial treatment, with available Chest pain QLQ-LC13 score at baseline and post-baseline)
TTDet is defined as the time from baseline to the first time that the patient's score shows a ≥10-point increase above baseline in the QLQ-LC13 'Chest pain' symptom. Patients with no definitive deterioration events will be censored at the date of the last available QoL assessment. Deterioration must be held for at least two consecutive assessments or be followed by PD and/or death within the next 3 weeks.
Outcome measures
| Measure |
Arm A
n=39 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=48 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Time to Deterioration (TTDet) in the QLQ-LC13 'Chest Pain' Symptom
|
NA months
Median deterioration time, lower and upper limit are not determined as there was an insufficient number of participants with events.
|
NA months
Interval 9.2 to
Median deterioration time and upper limit are not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization until documented progression (PD) outside the central nervous system (CNS) according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.Population: Intention-To-Treat cohort of all randomised patients
Extra-cranial progression-free-survival is the time from randomisation to documentation of disease progression outside the central nervous system (CNS) as per RECIST v1.1 or death, whichever occurred first.
Outcome measures
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Extra-cranial PFS
|
7.8 months
Interval 5.5 to 9.7
|
9.2 months
Interval 4.9 to 9.8
|
SECONDARY outcome
Timeframe: From randomization until first documented radiographic evidence of CNS progression according to RECIST v1.1 or death from any cause (whichever occurred first), up to 3 years.Population: Intention-To-Treat cohort of all randomised patients
Intracranial progression-free-survival is defined as the time from randomisation to first documented radiographic evidence of CNS progression or death, whichever occurred first. CNS progression is defined as progression due to newly developed CNS lesions and/or progression of pre-existing baseline CNS lesions.
Outcome measures
| Measure |
Arm A
n=45 Participants
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 Participants
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Intracranial PFS
|
8.3 months
Interval 5.7 to 15.4
|
12.3 months
Interval 9.8 to 15.8
|
Adverse Events
Arm A
Serious events: 19 serious events
Other events: 43 other events
Deaths: 26 deaths
Arm B
Serious events: 23 serious events
Other events: 49 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Arm A
n=44 participants at risk
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 participants at risk
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Fever
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Medically assisted suicide
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Non cardiac chest pain
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Hepatobiliary disorders
Cholangitis
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Immune system disorders
Cytokine release syndrome
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
COVID 19 infection
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Hepatic infection
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Lung infection
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Meningitis
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Shingles
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Urinary tract infection
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Neutrophil count decreased
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Synchronous urothelial carcinoma
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Encephalitis
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Hydrocephalus
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Paresthesia
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Stroke
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Psychiatric disorders
Depression
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemic respiratory failure
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pressure ulcers
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
Other adverse events
| Measure |
Arm A
n=44 participants at risk
* Atezolizumab (1200 mg) Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Carboplatin (AUC5) Q3W, 4-6 cycles
* Paclitaxel (175-200 mg/m2), Q3W, 4-6 cycles
|
Arm B
n=50 participants at risk
* Atezolizumab (1200 mg), Q3W, until PD
* Bevacizumab (15 mg/kg), Q3W, until PD
* Pemetrexed (500 mg/m2), Q3W, until PD
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
29.5%
13/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
38.0%
19/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Fatigue
|
29.5%
13/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
32.0%
16/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Vascular disorders
Hypertension
|
25.0%
11/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
34.0%
17/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Constipation
|
27.3%
12/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
30.0%
15/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Aspartate aminotransferase increased
|
15.9%
7/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
38.0%
19/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Renal and urinary disorders
Proteinuria
|
27.3%
12/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
18.0%
9/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
COVID 19 infection
|
20.5%
9/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
22.0%
11/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
6/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
26.0%
13/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
36.4%
16/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
11/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
14.0%
7/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.4%
5/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
24.0%
12/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Anorexia
|
11.4%
5/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
22.0%
11/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Headache
|
13.6%
6/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
20.0%
10/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Neutrophil count decreased
|
27.3%
12/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Serum amylase increased
|
18.2%
8/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
16.0%
8/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Fever
|
13.6%
6/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
14.0%
7/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Pain
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
18.0%
9/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
6/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
12.0%
6/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.9%
7/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
7/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
16.0%
8/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
12.0%
6/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.5%
9/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
GGT increased
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
18.0%
9/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
12.0%
6/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Lung infection
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Non cardiac chest pain
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Edema limbs
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
12.0%
6/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Psychiatric disorders
Insomnia
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Lipase increased
|
11.4%
5/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Mucositis oral
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.4%
5/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Paresthesia
|
11.4%
5/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Alkaline phosphatase increased
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Creatinine increased
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
10.0%
5/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Renal and urinary disorders
Dysuria
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Psychiatric disorders
Anxiety
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
4.0%
2/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.5%
2/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
8.0%
4/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
Platelet count decreased
|
6.8%
3/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
2.0%
1/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Investigations
White blood cell decreased
|
9.1%
4/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
0.00%
0/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Edema face
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
|
General disorders
Generalized edema
|
0.00%
0/44 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
6.0%
3/50 • Adverse events were assessed from randomization to 90 days after the last dose of trial treatment, up to 3 years.
An adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of randomisation until 90 days after the last dose of protocol treatment, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0. and assessed in safety population (patients who received at least 1 dose of trial treatment: 44 in arm A/50 in arm B). Of note, all-cause mortality was assessed for all randomized (45 in arm A/50 in arm B).
|
Additional Information
Dr. Heidi Roschitzki-Voser, PhD
ETOP IBCSG Partners Foundation
Phone: +41 31 511 94 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place