Trial Outcomes & Findings for Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer (NCT NCT00871403)
NCT ID: NCT00871403
Last Updated: 2013-06-20
Results Overview
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Randomization until progression or death (up to 85 weeks)
Results posted on
2013-06-20
Participant Flow
Per protocol, the study had 2 treatment arms: Arm 1, investigational (pazopanib+pemetrexed); and Arm 2, standard of care (cisplatin+pemetrexed). Protocol amendment 1 lowered the pazopanib starting dose (SD) for new Arm 1 participants from 800 to 600 milligrams. For clarity, safety/demography data for these different SDs are presented separately.
Participant milestones
| Measure |
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
|
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|---|
|
Combination Treatment Phase
STARTED
|
9
|
62
|
35
|
|
Combination Treatment Phase
COMPLETED
|
0
|
13
|
23
|
|
Combination Treatment Phase
NOT COMPLETED
|
9
|
49
|
12
|
|
Monotherapy Treatment Phase
STARTED
|
0
|
13
|
1
|
|
Monotherapy Treatment Phase
COMPLETED
|
0
|
0
|
0
|
|
Monotherapy Treatment Phase
NOT COMPLETED
|
0
|
13
|
1
|
Reasons for withdrawal
| Measure |
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
|
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|---|
|
Combination Treatment Phase
Randomized but Not Treated
|
1
|
1
|
1
|
|
Combination Treatment Phase
Treatment Stopped; Protocol Amendment
|
8
|
19
|
0
|
|
Combination Treatment Phase
Adverse Event
|
0
|
17
|
2
|
|
Combination Treatment Phase
Disease Progression
|
0
|
8
|
5
|
|
Combination Treatment Phase
Withdrawal by Subject
|
0
|
3
|
1
|
|
Combination Treatment Phase
Physician Decision
|
0
|
1
|
3
|
|
Monotherapy Treatment Phase
Disease Progression
|
0
|
9
|
1
|
|
Monotherapy Treatment Phase
Adverse Event
|
0
|
4
|
0
|
Baseline Characteristics
Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
n=9 Participants
Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
|
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=62 Participants
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=35 Participants
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
60.4 Years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
60.8 Years
STANDARD_DEVIATION 8.27 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
61.1 Years
STANDARD_DEVIATION 9.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
8 participants
n=5 Participants
|
59 participants
n=7 Participants
|
33 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomization until progression or death (up to 85 weeks)Population: Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion).
Outcome measures
| Measure |
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=62 Participants
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=35 Participants
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
25.0 weeks
Interval 17.3 to 34.1
|
22.9 weeks
Interval 18.4 to 27.7
|
SECONDARY outcome
Timeframe: Randomization until death (up to 85 weeks)Population: ITT Population
OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization until response or progressive disease (up to 85 weeks)Population: ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.
Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; \>=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=62 Participants
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=35 Participants
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|
|
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Complete response
|
0 participants
|
0 participants
|
|
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Partial response
|
14 participants
|
12 participants
|
|
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Progressive disease
|
6 participants
|
5 participants
|
|
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Unknown
|
29 participants
|
4 participants
|
|
Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only
Stable disease
|
13 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Randomization until response or progressive disease (up to 85 weeks)Population: ITT Population
The percentage of participants with a complete response or a partial response was evaluated.
Outcome measures
| Measure |
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=62 Participants
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=35 Participants
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|
|
Percentage of Participants With a Complete Response or a Partial Response
|
14 percentage of participants
|
12 percentage of participants
|
Adverse Events
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
Serious events: 34 serious events
Other events: 59 other events
Deaths: 0 deaths
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
Serious events: 12 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
n=8 participants at risk
Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
|
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=61 participants at risk
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=34 participants at risk
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Bronchopneumonia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Disease progression
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Pyrexia
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Chills
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Death
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Empyema
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Fatigue
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
General physical health deterioration
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Lung infection
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Necrotising fascitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
Other adverse events
| Measure |
Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2
n=8 participants at risk
Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m\^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
|
Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2
n=61 participants at risk
Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m\^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
|
Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2
n=34 participants at risk
IV cisplatin 75 mg/m\^2 plus intravenous pemetrexed 500 mg/m\^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
39.3%
24/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
61.8%
21/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
34.4%
21/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
17.6%
6/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
24.6%
15/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
35.3%
12/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
16.4%
10/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.5%
7/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.5%
7/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
32.4%
11/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
16.4%
10/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Asthenia
|
37.5%
3/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.5%
7/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
29.4%
10/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Pyrexia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.5%
7/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
20.6%
7/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
17.6%
6/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
59.0%
36/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
26.5%
9/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
21.3%
13/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
13.1%
8/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
23.5%
8/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
9.8%
6/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
20.6%
7/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
29.4%
10/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
21.3%
13/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
23.5%
8/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
13.1%
8/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
23.5%
8/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
9.8%
6/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
17.6%
6/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
18.0%
11/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
14.7%
5/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
18.0%
11/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Weight decreased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
14.8%
9/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
13.1%
8/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Transaminases increased
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
29.5%
18/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
3/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
21.3%
13/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
20.6%
7/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
14.8%
9/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.2%
5/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
6.6%
4/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
2.9%
1/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
9.8%
6/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
3.3%
2/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Eye disorders
Dry eye
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
4.9%
3/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
0.00%
0/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
8.8%
3/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
11.8%
4/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
1.6%
1/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
5.9%
2/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
|
General disorders
Fatigue
|
0.00%
0/8
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
39.3%
24/61
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
29.4%
10/34
Serious adverse events (SAEs) and non-serious AEs are presented for the entire treatment period (Combination Treatment Phase followed by the Monotherapy Phase). SAEs and AEs were collected in the Safety Population, comprised all participants who had received at least one dose of both drugs within the assigned regimen.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER