Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer. (NCT NCT01998919)
NCT ID: NCT01998919
Last Updated: 2015-01-13
Results Overview
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than \[\>\]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Week 8
Results posted on
2015-01-13
Participant Flow
Participant milestones
| Measure |
Placebo Plus Chemotherapy
Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m\^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 times \[x\] area under the serum concentration-time curve \[AUC\]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
74
|
|
Overall Study
Randomized
|
78
|
76
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
42
|
35
|
Reasons for withdrawal
| Measure |
Placebo Plus Chemotherapy
Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m\^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 times \[x\] area under the serum concentration-time curve \[AUC\]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Disease progression
|
31
|
22
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other
|
5
|
2
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Baseline characteristics by cohort
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
56.45 years
STANDARD_DEVIATION 10.245 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than \[\>\]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
|
76.9 percentage of participants
Interval 66.0 to 85.7
|
80.3 percentage of participants
Interval 69.5 to 88.5
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for \>16 weeks) per RECIST.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
|
53.8 percentage of participants
Interval 42.2 to 65.2
|
64.5 percentage of participants
Interval 52.7 to 75.1
|
SECONDARY outcome
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study PhasesPopulation: FAS
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
|
24.4 percentage of participants
Interval 15.3 to 35.4
|
36.8 percentage of participants
Interval 26.1 to 48.7
|
SECONDARY outcome
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study PhasesPopulation: FAS; only participants with CR or PR were included in the analysis.
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=19 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=28 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Duration of Response
|
24.1 weeks
Interval 17.0 to 33.0
|
38.4 weeks
Interval 25.0 to 77.0
|
SECONDARY outcome
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study PhasesPopulation: FAS Population
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Time to Progression
|
24.1 weeks
Interval 18.0 to 28.0
|
31.4 weeks
Interval 25.0 to 36.0
|
SECONDARY outcome
Timeframe: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study PhasesPopulation: FAS Population
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
23.4 weeks
Interval 17.0 to 25.0
|
30.4 weeks
Interval 24.0 to 34.0
|
SECONDARY outcome
Timeframe: Date of randomization until date of death or date of last follow-up assessmentPopulation: FAS Population
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Outcome measures
| Measure |
Placebo Plus Chemotherapy
n=78 Participants
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=76 Participants
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Overall Survival
|
75.7 weeks
Interval 60.0 to 105.0
|
74.1 weeks
Interval 49.0 to 100.0
|
Adverse Events
Placebo Plus Chemotherapy
Serious events: 17 serious events
Other events: 74 other events
Deaths: 0 deaths
Erlotinib Plus Chemotherapy
Serious events: 17 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Plus Chemotherapy
n=79 participants at risk
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=74 participants at risk
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Diverticulitis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Infection
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Fatigue
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Pain
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Pyrexia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
Other adverse events
| Measure |
Placebo Plus Chemotherapy
n=79 participants at risk
Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
|
Erlotinib Plus Chemotherapy
n=74 participants at risk
Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m\^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m\^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.1%
19/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
27.0%
20/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
7/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
23.0%
17/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
13.5%
10/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Nausea
|
46.8%
37/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
45.9%
34/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
29/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
29.7%
22/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Constipation
|
31.6%
25/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
29.7%
22/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.3%
20/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
35.1%
26/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
12.2%
9/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.8%
33/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
40.5%
30/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Fatigue
|
22.8%
18/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
31.1%
23/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Pyrexia
|
13.9%
11/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
13.5%
10/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Chest pain
|
12.7%
10/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Asthenia
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Mucosal inflammation
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
12/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
25.7%
19/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.5%
17/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
23.0%
17/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
14/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
18.9%
14/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.1%
8/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Psychiatric disorders
Insomnia
|
13.9%
11/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
12.2%
9/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Platelet count decreased
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
9.5%
7/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
White blood cell count decreased
|
8.9%
7/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Neutrophil count decreased
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Haemoglobin decreased
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
8.1%
6/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Dizziness
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
9.5%
7/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Dysgeusia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
6.8%
5/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
9.5%
7/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
9.5%
7/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
7/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Renal and urinary disorders
Renal impairment
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
5.4%
4/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.5%
32/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
64.9%
48/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
10.8%
8/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
12.2%
9/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Malaise
|
8.9%
7/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Alanine aminotransferase increased
|
10.1%
8/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
White blood cell count
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.3%
5/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Neutrophil count
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Headache
|
11.4%
9/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
6/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Hypertension
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.1%
4/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Renal and urinary disorders
Dysuria
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Hepatobiliary disorders
Hepatic lesion
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Cardiac disorders
Palpitations
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Cardiac disorders
Arrhythmia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Cardiac disorders
Tachycardia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Immune system disorders
Hypersensitivity
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Dry eye
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Vision blurred
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Abnormal sensation in eye
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Eye pruritus
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Lacrimation increased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Hypotension
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Flushing
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Vasculitis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Vein pain
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Vascular disorders
Venous thrombosis limb
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Pneumonia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Infection
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Nail infection
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Oral herpes
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Candidiasis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Sepsis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Tinea versicolour
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Psychiatric disorders
Anxiety
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Somnolence
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Cognitive disorder
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood creatinine increased
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Platelet count
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood sodium decreased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Haemoglobin
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Hepatic enzyme increased
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Weight decreased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Weight increased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Alanine aminotransferase
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Aspartate aminotransferase
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Blood pressure increased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Creatinine renal clearance decreased
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Investigations
Sputum abnormal
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Chest discomfort
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Pain
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Chills
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Influenza like illness
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Oedema peripheral
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Oedema
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Catheter site swelling
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Discomfort
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Face oedema
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
General disorders
Local swelling
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.8%
3/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
2/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
4.1%
3/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
2.7%
2/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Lip ulceration
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
1.3%
1/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
0.00%
0/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/79 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
1.4%
1/74 • Adverse events were recorded throughout primary and post-study treatment phases and for 28 days after last study dose.
The Safety Analysis Population (SAP) included all participants who received at least 1 dose/infusion and had at least 1 post-baseline safety assessment. For analysis, participants were assigned to the treatment group of the first received dose irrespective of subsequent changes in treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER