Trial Outcomes & Findings for Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma (NCT NCT04158141)
NCT ID: NCT04158141
Last Updated: 2025-02-19
Results Overview
Overall survival was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive at time of study termination is reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
Randomization to the date of death or last follow-up. Maximum follow-up time from randomization was 25 months.
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Registered, Not Yet Randomized
All patients are on Step 1 before being randomized to Step 2.
STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
|
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2: Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
STEP 1: Same as Arm 1.
STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|---|
|
Step 1: Registration
STARTED
|
16
|
0
|
0
|
|
Step 1: Registration
Eligible (Step 1)
|
16
|
0
|
0
|
|
Step 1: Registration
COMPLETED
|
11
|
0
|
0
|
|
Step 1: Registration
NOT COMPLETED
|
5
|
0
|
0
|
|
Step 2: Randomization
STARTED
|
0
|
5
|
6
|
|
Step 2: Randomization
Eligible (Step 2)
|
0
|
5
|
6
|
|
Step 2: Randomization
COMPLETED
|
0
|
5
|
6
|
|
Step 2: Randomization
NOT COMPLETED
|
0
|
0
|
0
|
|
Step 2: As-treated Population
STARTED
|
0
|
6
|
4
|
|
Step 2: As-treated Population
COMPLETED
|
0
|
6
|
4
|
|
Step 2: As-treated Population
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Registered, Not Yet Randomized
All patients are on Step 1 before being randomized to Step 2.
STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
|
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2: Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
STEP 1: Same as Arm 1.
STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|---|
|
Step 1: Registration
Does not meet requirements for Step 2
|
1
|
0
|
0
|
|
Step 1: Registration
Adverse Event
|
1
|
0
|
0
|
|
Step 1: Registration
Withdrawal by Subject
|
1
|
0
|
0
|
|
Step 1: Registration
Study terminated immediately after patient enrolled
|
2
|
0
|
0
|
Baseline Characteristics
This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
Baseline characteristics by cohort
| Measure |
Step 1 Only
n=5 Participants
Patients that did not continue to Step 2 (were not randomized). STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
|
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=5 Participants
STEP 1: Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2: Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 Participants
STEP 1: Same as Arm 1.
STEP 2: Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≤ 49 years
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=16 Participants
|
|
Age, Customized
50 - 59 years
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=16 Participants
|
|
Age, Customized
60 - 69 years
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=16 Participants
|
|
Age, Customized
≥ 70 years
|
4 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
14 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
11 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=16 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status at Registration
0
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status at Registration
1
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=16 Participants
|
|
Cell type
Biphasic mesothelioma
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=16 Participants
|
|
Cell type
Epithelioid
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
12 Participants
n=16 Participants
|
|
Macroscopic complete resection in Step 1
R0 (Complete resection)
|
—
|
1 Participants
n=5 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
3 Participants
n=6 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
4 Participants
n=11 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
|
Macroscopic complete resection in Step 1
R1 (Macroscopically complete resection)
|
—
|
3 Participants
n=5 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
3 Participants
n=6 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
6 Participants
n=11 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
|
Macroscopic complete resection in Step 1
R2 (Resection that leaves gross tumor behind)
|
—
|
1 Participants
n=5 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
0 Participants
n=6 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
1 Participants
n=11 Participants • This is only a baseline characteristic for Step 2, because surgery occurs during Step 1.
|
|
Yearly procedure volume at the patient's treatment center
< 10 pleurectomy/decortations
|
—
|
1 Participants
n=5 Participants • This data is only a reported baseline measure for Step 2.
|
2 Participants
n=6 Participants • This data is only a reported baseline measure for Step 2.
|
3 Participants
n=11 Participants • This data is only a reported baseline measure for Step 2.
|
|
Yearly procedure volume at the patient's treatment center
≥ 10 pleurectomy/decortations
|
—
|
4 Participants
n=5 Participants • This data is only a reported baseline measure for Step 2.
|
4 Participants
n=6 Participants • This data is only a reported baseline measure for Step 2.
|
8 Participants
n=11 Participants • This data is only a reported baseline measure for Step 2.
|
|
Pathologic AJCC Stage
IA (T1N0M0)
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=16 Participants
|
|
Pathologic AJCC Stage
IIA (T2bN0M0)
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
|
Pathologic AJCC Stage
IIB (T[1-2]N1M0,T3N0M0)
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=16 Participants
|
|
Pathologic AJCC Stage
IIIA (T[1-2]N2M0) (T3N1M0) (T4N[0-1]M0)
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Randomization to the date of death or last follow-up. Maximum follow-up time from randomization was 25 months.Population: Randomized patients
Overall survival was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive at time of study termination is reported.
Outcome measures
| Measure |
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=5 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From randomization to local failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.Population: Randomized patients
Local failure is defined as local enlargement (LE) or local failure (LF) tumor response, marginal failure (MF), or death. LFFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without failure at time of study termination is reported, and no statistical testing was done. LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on computed tomography (CT) scan. LF: Progression of pleural tumor thickness or appearance of a site of pleural thickness \> 5 mm in the site of treated tumor. MF: The appearance of a new measurable site of pleural tumor \> 5mm within the treated site or enlarging tumor dimensions corresponding to a 20% increase in LD compared to initial appearance on imaging evaluation.
Outcome measures
| Measure |
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=5 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|
|
Local-failure-free Survival (LFFS)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From randomization to distant failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.Population: Randomized patients
Distant failure (DF) is defined as the appearance of cancer deposits characteristic of metastatic dissemination from mesothelioma. DMFS was to be estimated by the Kaplan-Meier method and arms were to be compared using a log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without failure at time of study termination is reported, and no statistical testing was done.
Outcome measures
| Measure |
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=5 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|
|
Distant-metastases-free Survival (DMFS)
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomization to first progression, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.Population: Randomized patients
Progression is defined as LE, LF, MF, DF, or death. PFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when ≥ 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without progression at study termination is reported, and no statistical testing was done. LE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on CT scan. LF: Progression of pleural tumor thickness or appearance of a site of pleural thickness \> 5 mm in the site of treated tumor. MF: The appearance of a new measurable site of pleural tumor \> 5mm within the treated site or enlarging tumor dimensions corresponding to a 20% increase in LD compared to initial appearance on imaging evaluation. DF: The appearance of cancer deposits characteristic of metastatic dissemination
Outcome measures
| Measure |
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=5 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomization to death or last follow-up. Maximum follow-up time was 25 months.Population: Randomized patients who received protocol treatment and were assessed for adverse events. Arms determined by Step 2 treatment received (as-treated).
Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events.
Outcome measures
| Measure |
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=6 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=4 Participants
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|
|
Number of Patients With Grade 3 or Higher Treatment-related Adverse Event After Randomization
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Randomization and 9 monthsPopulation: No patients had both baseline and 9-month data, therefore change from baseline could not be calculated for any patient.
Global Health Status is calculated from two questions on the EORTC QLQ-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsFor each subject, the centrally-reviewed clinical staging (based on positron emission tomography, computed tomography and/or magnetic resonance imaging) will be compared with pathologic staging to determine whether it is under-staging (clinical staging is more extensive than pathologic staging), concordant (clinical staging is same as pathologic staging), or upstaging (clinical staging is less extensive than pathologic staging).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsGross residual disease and local failure will be analyzed as competing risk data (death without gross residual disease or death without local failure as the respective competing event). Association between radiation dose to gross residual disease and local failure will be evaluated similarly in multivariable analyses using Fine-Gray regression model.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsProportions of R0/R1 and R2 resections, by type of procedures (extended pleurectomy/decortication (P/D), P/D and partial pleurectomy).
Outcome measures
Outcome data not reported
Adverse Events
Pre-randomization
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-randomization
n=13 participants at risk
All patients in Step 1.
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
|
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
n=4 participants at risk
\[Intent-to-treat\]
STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
STEP 2 (randomized): Patients receive no treatment.
|
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
n=6 participants at risk
\[Intent-to-treat\]
STEP 1 (all patients): Same as Arm 1.
STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Eye disorders
Eye disorders - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Eye disorders
Watering eyes
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Chylous ascites
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
General disorders
Edema limbs
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
General disorders
Fatigue
|
61.5%
8/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
33.3%
2/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
General disorders
Generalized edema
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
General disorders
Pain
|
30.8%
4/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
25.0%
1/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Infections and infestations
Papulopustular rash
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Infections and infestations
Wound infection
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Blood bicarbonate decreased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Creatinine increased
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Investigations - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Lipase increased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.8%
4/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Dysesthesia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Psychiatric disorders
Delirium
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Psychiatric disorders
Depression
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
25.0%
1/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Psychiatric disorders
Insomnia
|
30.8%
4/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
25.0%
1/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
25.0%
1/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
3/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
15.4%
2/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
16.7%
1/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Vascular disorders
Hypotension
|
23.1%
3/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
7.7%
1/13 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/4 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
0.00%
0/6 • Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
|
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