Trial Outcomes & Findings for Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer (NCT NCT01244191)
NCT ID: NCT01244191
Last Updated: 2021-04-06
Results Overview
The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1048 participants
Primary outcome timeframe
Date of randomization up to date of death, up to approximately 1 year 11 months postdose
Results posted on
2021-04-06
Participant Flow
A total of 1048 participants who met all inclusion criteria and no exclusion criteria were enrolled between 11 Jan 2011 and 18 Jul 2012 at 140 sites in Europe, 78 sites in United States, 32 sites in Latin America, and 20 sites in Canada/Australia. Of the 1048 participants, a total of 1037 participants received treatment.
Participants were to be randomized in a 1:1 ratio to tivantinib at 360 mg BID (total daily dose, 720 mg) + erlotinib at 150 mg QD, or placebo BID + erlotinib at 150 mg QD, to be administered in a double-blinded manner.
Participant milestones
| Measure |
Tivantinib and Erlotinib
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
526
|
522
|
|
Overall Study
Did Not Receive Treatment
|
6
|
5
|
|
Overall Study
COMPLETED
|
46
|
24
|
|
Overall Study
NOT COMPLETED
|
480
|
498
|
Reasons for withdrawal
| Measure |
Tivantinib and Erlotinib
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Overall Study
Progressive disease
|
295
|
350
|
|
Overall Study
Clinical disease progression
|
54
|
36
|
|
Overall Study
Adverse Event
|
65
|
48
|
|
Overall Study
Death
|
22
|
29
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
31
|
23
|
|
Overall Study
'Missing' or 'Terminated by sponsor'
|
12
|
8
|
Baseline Characteristics
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Tivantinib and Erlotinib
n=526 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=522 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
Total
n=1048 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
320 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
646 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
206 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 9.84 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
310 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of randomization up to date of death, up to approximately 1 year 11 months postdosePopulation: Overall survival was assessed in the Intent-to-treat population.
The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=526 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=522 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
|
8.5 months
Interval 7.1 to 9.3
|
7.8 months
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdosePopulation: Progression-free survival (PFS) was assessed in the Intent-to-treat population.
Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=526 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=522 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
|
3.6 months
Interval 2.8 to 3.7
|
1.9 months
Interval 1.9 to 2.0
|
SECONDARY outcome
Timeframe: Date of randomization up to date of death, up to approximately 1 year 11 months postdosePopulation: Overall survival was assessed in participants with the epidermal growth factor receptor wild-type gene.
The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=469 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=468 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
|
7.2 months
Interval 6.4 to 8.5
|
7.1 months
Interval 6.3 to 7.8
|
SECONDARY outcome
Timeframe: Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdosePopulation: Progression-free survival (PFS) was assessed in participants with the epidermal growth factor receptor wild-type gene.
Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=469 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=468 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC
|
2.7 months
Interval 1.9 to 3.6
|
1.9 months
Interval 1.9 to 1.9
|
SECONDARY outcome
Timeframe: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdosePopulation: Best overall response was assessed in the Intent-to-treat population.
The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=526 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=522 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Complete response (CR)
|
1 Participants
|
1 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Partial response (PR)
|
53 Participants
|
33 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Objective response (CR+PR)
|
54 Participants
|
34 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Stable disease (SD)
|
187 Participants
|
133 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Progressive disease (PD)
|
189 Participants
|
265 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Best response of SD or better
|
241 Participants
|
167 Participants
|
|
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Inevaluable
|
96 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdosePopulation: Duration of response was assessed in the Intent-to-treat population.
Duration of response was defined for participants with confirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=241 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=167 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Duration of objective response (CR or PR)
|
40.43 weeks
Interval 0.1 to 56.1
|
47.86 weeks
Interval 0.1 to 79.7
|
|
Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer
Duration of SD
|
28.29 weeks
Interval 7.9 to 80.0
|
23.86 weeks
Interval 7.7 to 79.3
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 1 year 11 months postdosePopulation: Adverse events were assessed in the Safety population.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=520 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=517 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Any TEAE
|
513 Participants
|
503 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Diarrhea
|
180 Participants
|
212 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Rash
|
172 Participants
|
193 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Decreased appetite
|
151 Participants
|
149 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Dyspnea
|
136 Participants
|
117 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Fatigue
|
136 Participants
|
113 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Nausea
|
121 Participants
|
123 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Cough
|
110 Participants
|
91 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Asthenia
|
100 Participants
|
90 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Dermatitis acneiform
|
90 Participants
|
98 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Vomiting
|
73 Participants
|
81 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Anemia
|
83 Participants
|
51 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Weight decreased
|
57 Participants
|
58 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Constipation
|
57 Participants
|
54 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Pyrexia
|
60 Participants
|
41 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Back pain
|
54 Participants
|
47 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Dry skin
|
41 Participants
|
56 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Pruritus
|
31 Participants
|
44 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Neutropenia
|
62 Participants
|
10 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Headache
|
41 Participants
|
28 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Edema, peripheral
|
37 Participants
|
29 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Insomnia
|
33 Participants
|
29 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Abdominal pain
|
34 Participants
|
27 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Noncardiac chest pain
|
34 Participants
|
24 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Pneumonia
|
35 Participants
|
22 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Dyspepsia
|
30 Participants
|
24 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Abdominal pain, upper
|
33 Participants
|
19 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Mucosal inflammation
|
27 Participants
|
24 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Stomatitis
|
22 Participants
|
27 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Hemoptysis
|
30 Participants
|
19 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
General physical health deterioration
|
29 Participants
|
18 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Pain in extremity
|
28 Participants
|
19 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Dizziness
|
26 Participants
|
16 Participants
|
|
Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer
Alopecia
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose, up to 1 year 11 months postdosePopulation: Adverse events were assessed in the Safety population.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration.
Outcome measures
| Measure |
Tivantinib and Erlotinib
n=520 Participants
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=517 Participants
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
TEAE related to tivantinib/placebo
|
324 Participants
|
301 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Blood and Lymphatic System Disorders
|
87 Participants
|
27 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Anemia
|
44 Participants
|
17 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Neutropenia
|
54 Participants
|
5 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Gastrointestinal Disorders
|
165 Participants
|
163 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Diarrhea
|
81 Participants
|
96 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Nausea
|
63 Participants
|
68 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Vomiting
|
31 Participants
|
39 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
General Disorders & Administration Site Conditions
|
135 Participants
|
114 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Asthenia
|
43 Participants
|
38 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Fatigue
|
78 Participants
|
63 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Metabolism and Nutrition Disorders
|
82 Participants
|
84 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Decreased appetite
|
73 Participants
|
71 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Skin and Subcutaneous Tissue Disorders
|
148 Participants
|
130 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Dermatitis acneiform
|
26 Participants
|
27 Participants
|
|
Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC
Rash
|
61 Participants
|
71 Participants
|
Adverse Events
Tivantinib and Erlotinib
Serious events: 219 serious events
Other events: 513 other events
Deaths: 77 deaths
Placebo and Erlotinib
Serious events: 191 serious events
Other events: 503 other events
Deaths: 65 deaths
Serious adverse events
| Measure |
Tivantinib and Erlotinib
n=520 participants at risk
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=517 participants at risk
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
General disorders
Asthenia
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.97%
5/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Fatigue
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Malaise
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
16/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.2%
6/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
15/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
11/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
General physical health deterioration
|
2.9%
15/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
2.5%
13/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Pneumonia
|
3.8%
20/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
2.1%
11/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
29/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
4.8%
25/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
12/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.7%
9/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
17/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.5%
18/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Bradycardia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardiac failure
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Pericarditis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Pericarditis restrictive
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Eye disorders
Diplopia
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.2%
6/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Ileus
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Melaena
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.2%
6/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Subileus
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Mucosal inflammation
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Multi-organ disorder
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Multi-organ failure
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Non-cardiac chest pain
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Pain
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Performance status decreased
|
0.96%
5/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Pyrexia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.97%
5/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Sudden death
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Bronchitis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.97%
5/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Bronchopneumonia
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Empyema
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Escherichia infection
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Genital infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Lobar pneumonia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Lung infection
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Perirectal abscess
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Pyothorax
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Sepsis
|
0.96%
5/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Septic shock
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Skin infection
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Injury, poisoning and procedural complications
Stemal fracture
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Blood creatinine increased
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Coagulation test abnormal
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Hepatic enzyme increased
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Neutrophil count decreased
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Weight decreased
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
White blood cell count decreased
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
White blood cell count increased
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.4%
7/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.96%
5/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Aphasia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Balance disorder
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Brain compression
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Brain stem infarction
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Coma
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Convulsion
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.97%
5/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Epiduritis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Hemiparesis
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Nervous system disorder
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Neurological decompensation
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Spinal cord compression
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Psychiatric disorders
Anxiety
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Psychiatric disorders
Confusional state
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Psychiatric disorders
Mental status changes
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Renal and urinary disorders
Renal failure
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse aveolar damage
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.77%
4/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.58%
3/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.96%
5/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
12/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.7%
9/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.77%
4/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.39%
2/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.19%
1/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.38%
2/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Phlebitis
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Shock
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Superior vena caval occulsion
|
0.00%
0/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.58%
3/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Venous insufficiency
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Vascular disorders
Venous thrombosis limb
|
0.19%
1/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
0.00%
0/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
Other adverse events
| Measure |
Tivantinib and Erlotinib
n=520 participants at risk
Participants who were randomized to receive Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day.
|
Placebo and Erlotinib
n=517 participants at risk
Participants who were randomized to receive Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.0%
83/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
9.9%
51/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.9%
62/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
1.9%
10/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
34/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
5.2%
27/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
6.3%
33/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.7%
19/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
11.0%
57/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
10.4%
54/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Diarrhea
|
34.6%
180/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
41.0%
212/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
30/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
4.6%
24/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
23.3%
121/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
23.8%
123/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
22/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
5.2%
27/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
73/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
15.7%
81/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Asthenia
|
19.2%
100/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
17.4%
90/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Fatigue
|
26.2%
136/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
21.9%
113/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
General physical health deterioration
|
5.6%
29/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.5%
18/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Mucosal inflammation
|
5.2%
27/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
4.6%
24/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Noncardiac chest pain
|
6.5%
34/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
4.6%
24/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Edema, peripheral
|
7.1%
37/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
5.6%
29/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
General disorders
Pyrexia
|
11.5%
60/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
7.9%
41/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Infections and infestations
Pneumonia
|
6.7%
35/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
4.3%
22/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Investigations
Weight decreased
|
11.0%
57/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
11.2%
58/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.0%
151/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
28.8%
149/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
54/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
9.1%
47/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
28/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.7%
19/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Dizziness
|
5.0%
26/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.1%
16/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Nervous system disorders
Headache
|
7.9%
41/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
5.4%
28/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Psychiatric disorders
Insomnia
|
6.3%
33/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
5.6%
29/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.2%
110/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
17.6%
91/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.2%
136/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
22.6%
117/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
5.8%
30/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
3.7%
19/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
26/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
2.7%
14/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.3%
90/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
19.0%
98/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
41/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
10.8%
56/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
31/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
8.5%
44/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.1%
172/520 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
37.3%
193/517 • Adverse events were collected from baseline up to 30 days after last dose, up to approximately 1 year 11 months postdose.
Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. Safety events were assessed in the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place