Trial Outcomes & Findings for Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer (NCT NCT03137771)
NCT ID: NCT03137771
Last Updated: 2025-11-25
Results Overview
Progression-free survival (PFS) is estimated by the Kaplan-Meier method. Progression-free survival time is measured from randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after progression or death was reported for 138 participants.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
218 participants
Primary outcome timeframe
From randomization to first date of local or regional disease, distant metastases, second primary tumor, death, or last follow-up, whichever comes first. Maximum follow-up time at time of analysis was 5.4 years.
Results posted on
2025-11-25
Participant Flow
Participant milestones
| Measure |
Arm 1 (systemic maintenance chemotherapy)
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (LCT + systemic maintenance chemotherapy)
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of stereotactic body radiation therapy (SBRT)/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using intensity modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3D-CRT) can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
136
|
|
Overall Study
Modified intent-to-treat (MITT) population
|
81
|
134
|
|
Overall Study
COMPLETED
|
81
|
134
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Systemic Maintenance Chemotherapy)
n=81 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (LCT + Systemic Maintenance Chemotherapy)
n=134 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 49 years
|
4 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
|
Age, Customized
50 - 59 years
|
15 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
44 Participants
n=9 Participants
|
|
Age, Customized
60 - 69 years
|
31 Participants
n=9 Participants
|
56 Participants
n=6 Participants
|
87 Participants
n=9 Participants
|
|
Age, Customized
≥ 70 years
|
31 Participants
n=9 Participants
|
45 Participants
n=6 Participants
|
76 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=9 Participants
|
66 Participants
n=6 Participants
|
107 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=9 Participants
|
68 Participants
n=6 Participants
|
108 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=9 Participants
|
118 Participants
n=6 Participants
|
196 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
35 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=9 Participants
|
106 Participants
n=6 Participants
|
165 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
|
Zubrod performance status
0
|
35 Participants
n=9 Participants
|
47 Participants
n=6 Participants
|
82 Participants
n=9 Participants
|
|
Zubrod performance status
1
|
44 Participants
n=9 Participants
|
79 Participants
n=6 Participants
|
123 Participants
n=9 Participants
|
|
Zubrod performance status
2
|
2 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Histology
Non-Squamous cell carcinoma
|
64 Participants
n=9 Participants
|
104 Participants
n=6 Participants
|
168 Participants
n=9 Participants
|
|
Histology
Squamous cell carcinoma
|
17 Participants
n=9 Participants
|
30 Participants
n=6 Participants
|
47 Participants
n=9 Participants
|
|
Systemic Therapy Type
Cytotoxic Chemotherapy
|
14 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
|
Systemic Therapy Type
Immunotherapy
|
67 Participants
n=9 Participants
|
118 Participants
n=6 Participants
|
185 Participants
n=9 Participants
|
|
Number of lesions targeted during treatment
1
|
50 Participants
n=9 Participants
|
78 Participants
n=6 Participants
|
128 Participants
n=9 Participants
|
|
Number of lesions targeted during treatment
2
|
19 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
55 Participants
n=9 Participants
|
|
Number of lesions targeted during treatment
3
|
12 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
|
Number of lesions targeted during treatment
4
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Number of lesions targeted during treatment
5
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From randomization to first date of local or regional disease, distant metastases, second primary tumor, death, or last follow-up, whichever comes first. Maximum follow-up time at time of analysis was 5.4 years.Population: Modified intent-to-treat population (randomized eligible participants).
Progression-free survival (PFS) is estimated by the Kaplan-Meier method. Progression-free survival time is measured from randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after progression or death was reported for 138 participants.
Outcome measures
| Measure |
Arm 2 (LCT + systemic maintenance chemotherapy)
n=134 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Arm 1 (systemic maintenance chemotherapy)
n=81 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
[Phase II] Progression-free Survival
|
13.7 months
Interval 8.6 to 20.1
|
11.1 months
Interval 6.9 to 21.4
|
PRIMARY outcome
Timeframe: From randomization to death or last follow-up.Population: The phase III component did not open, therefore there are no participants for this outcome measure.
Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after \*\*\*\* deaths were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to first in-field failure, death or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 5.4 years. The one- and two-year estimates are reported.Population: Modified intent-to-treat population (randomized eligible participants).
In-field local failure is defined as local or marginal failure. In-field local failure rates are estimated by the cumulative incidence method, in which death without failure is treated as competing risk and participants alive without failure are censored at last known follow-up. Analysis was to occur after progression or death was reported for 138 participants.
Outcome measures
| Measure |
Arm 2 (LCT + systemic maintenance chemotherapy)
n=134 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Arm 1 (systemic maintenance chemotherapy)
n=81 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
In-Field Local Failure
2 years
|
13.4 percentage of participants
Interval 8.1 to 20.0
|
19.8 percentage of participants
Interval 11.4 to 29.9
|
|
In-Field Local Failure
1 year
|
8.6 percentage of participants
Interval 4.6 to 14.3
|
15.3 percentage of participants
Interval 8.1 to 24.6
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of any new lesions, death, or last follow-up, whichever occurs first. Maximum follow-up time at the time of analysis was 5.4 years. One- and two-year estimates are reported.Population: Modified intent-to-treat population (randomized eligible participants).
New lesion rates are estimated by the cumulative incidence method, in which death without new lesions is treated as competing risk and participants alive without new lesions are censored at last known follow-up. Analysis was to occur after progression or death was reported for 138 participants.
Outcome measures
| Measure |
Arm 2 (LCT + systemic maintenance chemotherapy)
n=134 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Arm 1 (systemic maintenance chemotherapy)
n=81 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Development of New Lesions
1 year
|
28.1 percentage of participants
Interval 20.6 to 36.1
|
32.5 percentage of participants
Interval 21.8 to 43.5
|
|
Development of New Lesions
2 years
|
30.5 percentage of participants
Interval 22.7 to 38.6
|
41.5 percentage of participants
Interval 29.7 to 52.9
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 5.4 years.Population: Modified intent-to-treat population (randomized and eligible) who received any protocol treatment.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Arm 2 (LCT + systemic maintenance chemotherapy)
n=130 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Arm 1 (systemic maintenance chemotherapy)
n=73 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 1
|
6 Participants
|
7 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 2
|
37 Participants
|
15 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 3
|
56 Participants
|
35 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 4
|
20 Participants
|
11 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 5
|
10 Participants
|
4 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
None
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomization to last chemotherapy, which continues until progression or significant toxicity. Maximum follow-up at time of analysis was 5.4 years.Population: Modified intent-to-treat population (randomized eligible participants).
Duration of Maintenance Chemotherapy
Outcome measures
| Measure |
Arm 2 (LCT + systemic maintenance chemotherapy)
n=134 Participants
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
Arm 1 (systemic maintenance chemotherapy)
n=81 Participants
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Maintenance Chemotherapy
|
6.20 months
Interval 2.81 to 16.86
|
5.46 months
Interval 2.07 to 17.95
|
Adverse Events
Arm 1 (systemic maintenance chemotherapy)
Serious events: 14 serious events
Other events: 71 other events
Deaths: 37 deaths
Arm 2 (LCT + systemic maintenance chemotherapy)
Serious events: 40 serious events
Other events: 129 other events
Deaths: 70 deaths
Serious adverse events
| Measure |
Arm 1 (systemic maintenance chemotherapy)
n=73 participants at risk
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (LCT + systemic maintenance chemotherapy)
n=130 participants at risk
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Death NOS
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Sudden death NOS
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Lung infection
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
White blood cell decreased
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Seizure
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
5.4%
7/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.00%
0/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
Other adverse events
| Measure |
Arm 1 (systemic maintenance chemotherapy)
n=73 participants at risk
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm 2 (LCT + systemic maintenance chemotherapy)
n=130 participants at risk
Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3DCRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.
|
|---|---|---|
|
Eye disorders
Dry eye
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Eye disorders
Eye disorders - Other
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Eye disorders
Eye pain
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Eye disorders
Watering eyes
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.8%
13/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
18.5%
24/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
30.1%
22/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
26.2%
34/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
30.1%
22/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
25.4%
33/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
16.9%
22/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
16.9%
22/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.0%
13/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.5%
31/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
35.4%
46/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
15/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
20.0%
26/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Chills
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Edema face
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Edema limbs
|
26.0%
19/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
19.2%
25/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Fatigue
|
57.5%
42/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
70.0%
91/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Fever
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
15.4%
20/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Gait disturbance
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
5.4%
7/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
8.5%
11/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Localized edema
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
15.4%
20/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
General disorders and administration site conditions
Pain
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Lung infection
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
17.7%
23/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Sepsis
|
4.1%
3/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
5.4%
7/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Skin infection
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
16.4%
12/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
8.5%
11/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.5%
15/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
18.5%
24/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
14.6%
19/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
21.9%
16/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
15.4%
20/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Cholesterol high
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Creatinine increased
|
27.4%
20/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
26.2%
34/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Investigations - Other
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
46.6%
34/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
51.5%
67/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Cardiac disorders - Other
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Endocrine disorders
Hypothyroidism
|
20.5%
15/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Eye disorders
Blurred vision
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
21.9%
16/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
43.8%
57/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Neutrophil count decreased
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
12.3%
16/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Platelet count decreased
|
15.1%
11/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
20.0%
26/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Thyroid stimulating hormone increased
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Weight gain
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
5.4%
7/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
Weight loss
|
17.8%
13/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
19.2%
25/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Investigations
White blood cell decreased
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
23.8%
31/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.0%
19/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
29.2%
38/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.8%
18/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.6%
26/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
26.9%
35/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
12.3%
16/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
24.7%
18/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
16.9%
22/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
8.5%
11/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
24.7%
18/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
25.4%
33/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.1%
3/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.1%
22/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
23.8%
31/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.9%
16/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
24.6%
32/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
11.0%
8/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.5%
15/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
14.6%
19/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.5%
15/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Concentration impairment
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
21.9%
16/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
24.6%
32/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Dysesthesia
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Headache
|
27.4%
20/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
20.8%
27/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Memory impairment
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
9.2%
12/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Paresthesia
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
8.5%
11/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
2.3%
3/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.8%
13/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
18.5%
24/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Nervous system disorders
Tremor
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
15.1%
11/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.0%
13/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Psychiatric disorders
Depression
|
15.1%
11/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
19.2%
25/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Dysuria
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.1%
4/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Renal and urinary disorders
Urinary urgency
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
1.5%
2/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.9%
9/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.4%
20/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
37.7%
49/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.0%
27/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
48.5%
63/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.7%
2/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
6.2%
8/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
17.7%
23/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.1%
11/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
14.6%
19/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
3/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.8%
14/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.1%
11/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
18.5%
24/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
26.9%
35/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
0.77%
1/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.1%
3/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
1/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
11.5%
15/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
5.4%
7/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
7/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
4.6%
6/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.2%
6/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
7.7%
10/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.7%
10/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
16.2%
21/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.3%
9/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
10.0%
13/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
16.4%
12/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
14.6%
19/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Hot flashes
|
6.8%
5/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
3.8%
5/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Hypertension
|
32.9%
24/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
23.8%
31/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
|
Vascular disorders
Hypotension
|
5.5%
4/73 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
13.1%
17/130 • From baseline to date of last known follow-up. Maximum follow-up time was 5.4 years.
All-cause mortality was assessed in the modified intent-to-treat population (MITT) (randomized and eligible). Adverse events were assessed in the MITT population that started protocol treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER