Trial Outcomes & Findings for Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors (NCT NCT01970540)
NCT ID: NCT01970540
Last Updated: 2020-03-09
Results Overview
A minimum of three patients will be included at each DL. If no patients experience a DLT during Cycle 1, the dose will be escalated. If one of three patients experiences a DLT, three additional patients will be included at that level. If \>1 evaluable patient during dose escalation at a given DL experience a DLT during Cycle 1, that DL will be considered the MTD and dose escalation will be terminated, except if all DLTs are related to neutropenia exclusively, in which case dose escalation may be resumed as originally planned in a new cohort of patients but with compulsory primary G-CSF prophylaxis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
122 participants
Primary outcome timeframe
During the first cycle of treatment, up to 28 days
Results posted on
2020-03-09
Participant Flow
122 patients were enrolled at 7 sites. 120 patients were treated with DOX/PM01183 combination: 73 Cohort A (DOX \[mg/m2\]+PM01183 \[mg FD\]) \& 47 Cohort B (DOX \[mg/m2\]+PM01183 \[mg/m2\]). Patients participated between 25May2011-9Aug2017 (last followup). First dose of the first cycle was given on 13Jun2011 and last dose of the last cycle on 19Jul2017
Screening details: Age 18-75;CI signed;ECOG PS≤1;histologically/cytologically confirmed diagnosis of advanced disease;Life expectancy≥3 months;not previously treated with anthracycline-containing therapy for advanced disease;No more than two prior lines of cytotoxic-containing chemotherapy regimens;CPK≤2.5xULN;Albumin≥2.5 g/dL
Participant milestones
| Measure |
Cohort A
DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
|
Cohort B: SCLC 2nd Line
Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
SCLC, small cell lung cancer
|
Cohort B: Endometrial
Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
28
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
73
|
28
|
19
|
Reasons for withdrawal
| Measure |
Cohort A
DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
|
Cohort B: SCLC 2nd Line
Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
SCLC, small cell lung cancer
|
Cohort B: Endometrial
Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
lurbinectedin (PM01183): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Doxorubicin: Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
|
|---|---|---|---|
|
Overall Study
Non-treatment-related AE
|
0
|
0
|
1
|
|
Overall Study
Progressive disease
|
55
|
23
|
10
|
|
Overall Study
Treatment delay over protocol
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
7
|
2
|
0
|
|
Overall Study
Clinical progression
|
0
|
1
|
1
|
|
Overall Study
End of study
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
|
Overall Study
Treatment-related AE
|
4
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
1
|
|
Overall Study
Clinical deterioration
|
1
|
0
|
0
|
Baseline Characteristics
Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort A
n=73 Participants
DOX: 50 mg/m² q3wk immediately followed by PM01183. The dose escalation scheme was: 3.0, 3.5, 5.0, 6.0, 7.0 mg FD
|
Cohort B: SCLC 2nd Line
n=28 Participants
Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 Immediately followed by PM01183: 2.0 mg/m2.
|
Cohort B: Endometrial
n=19 Participants
Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
53 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Categorical
Age · >=65 years
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Continuous
|
62.2 years
n=5 Participants
|
64 years
n=7 Participants
|
66 years
n=5 Participants
|
62.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race : Caucasian
|
72 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race : Asian/oriental
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race : Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
ECOG PS
PS 0
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
ECOG PS
PS 1
|
46 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
ECOG PS
PS 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Tumor type
SCLC 2 line
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Tumor type
SCLC 3 line
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Tumor type
Endometrial
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Tumor type
NET-GEP
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Tumor type
STS
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Tumor type
Bladder
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Tumor type
Gastric
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Tumor type
Breast
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Tumor type
Ovarian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Tumor type
HCC
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Lines of prior anticancer therapies
0 lines
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Lines of prior anticancer therapies
1 line
|
42 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Lines of prior anticancer therapies
2 lines
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Lines of prior anticancer therapies
3 lines
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Lines of prior anticancer therapies
>3 lines
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Body surface area
|
1.8 m^2
n=5 Participants
|
1.9 m^2
n=7 Participants
|
1.8 m^2
n=5 Participants
|
1.8 m^2
n=4 Participants
|
|
Time from diagnosis to first infusion
|
16.2 months
n=5 Participants
|
8.4 months
n=7 Participants
|
22.0 months
n=5 Participants
|
16.2 months
n=4 Participants
|
|
Time from last progressive disease to first infusion
|
0.9 months
n=5 Participants
|
0.9 months
n=7 Participants
|
1.3 months
n=5 Participants
|
0.9 months
n=4 Participants
|
|
Time to progression of last prior therapy
|
6.3 months
n=5 Participants
|
6.8 months
n=7 Participants
|
7.1 months
n=5 Participants
|
6.7 months
n=4 Participants
|
|
Sites of disease at baseline
|
2 number of sites
n=5 Participants
|
3 number of sites
n=7 Participants
|
2 number of sites
n=5 Participants
|
2 number of sites
n=4 Participants
|
|
Lines of prior anticancer therapies
|
1 lines of therapies
n=5 Participants
|
1 lines of therapies
n=7 Participants
|
1 lines of therapies
n=5 Participants
|
1 lines of therapies
n=4 Participants
|
|
Agents of prior anticancer therapies
|
2 Agents therapies
n=5 Participants
|
2 Agents therapies
n=7 Participants
|
2 Agents therapies
n=5 Participants
|
2 Agents therapies
n=4 Participants
|
PRIMARY outcome
Timeframe: During the first cycle of treatment, up to 28 daysPopulation: Fifty-seven of the 61 patients treated in this cohort without primary G-CSF prophylaxis were evaluable for DLTs Eleven of the 12 patients treated with primary G-CSF prophylaxis in this cohort were evaluable for DLTs.
A minimum of three patients will be included at each DL. If no patients experience a DLT during Cycle 1, the dose will be escalated. If one of three patients experiences a DLT, three additional patients will be included at that level. If \>1 evaluable patient during dose escalation at a given DL experience a DLT during Cycle 1, that DL will be considered the MTD and dose escalation will be terminated, except if all DLTs are related to neutropenia exclusively, in which case dose escalation may be resumed as originally planned in a new cohort of patients but with compulsory primary G-CSF prophylaxis.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=57 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=11 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
Doxorubicin
|
50 DOX mg/m2 PM01183 mg FD
|
50 DOX mg/m2 PM01183 mg FD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (MTD)
PM01183
|
5.0 DOX mg/m2 PM01183 mg FD
|
5.0 DOX mg/m2 PM01183 mg FD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the first cycle of treatment, up to 28 daysPopulation: Fifty-seven of the 61 patients treated in this cohort without primary G-CSF prophylaxis were evaluable for DLTs
The DL immediately below the MTD, or DL4 if the MTD is not yet defined during dose escalation before the last DL (i.e., DL4) is reached, was to be initially expanded up to a minimum of nine evaluable patients. If less than three among the first nine evaluable patients treated within the expansion cohort experience a DLT during Cycle 1, this DL will be the RD.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=57 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose (RD)
PM01183
|
4.0 DOX mg/m2 PM01183 mg FD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Recommended Dose (RD)
Doxorubicin
|
50 DOX mg/m2 PM01183 mg FD
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the first cycle of treatment, up to 28 daysPopulation: Patients evaluable for the primary endpoint (evaluable for DLT): 5 patients were not evaluable in Cohort A and 1 patient in Cohort B.
DLT,dose-limiting toxicity Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis. However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I in the present study (see below) suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=5 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=7 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
n=3 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
n=37 Participants
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
n=5 Participants
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
n=3 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
n=3 Participants
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
n=5 Participants
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
n=46 Participants
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities
|
2 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Tumor assessments were done every six weeks up to study completionPopulation: Cohort A: 1 patient of 73 was not evaluable: extensive bone marrow involvement
Tumor response was evaluated according to the RECIST v.1.1 for target lesions and assessed by computed tomography (CT) scans or magnetic resonance imagings (MRIs): Progressive disease (PD) is declared when there is an increase in sum of target disease ≥ 20%, stable diease (SD) when the change is \> -30% and ≤ 20%, partial response (PR) when there is a decrease in sum of target disease ≥ 30%, and complete response (CR) when all lesions have disappeared or all lesions have disapeared and all nodal disease is \< 10 mm each.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=72 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=28 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
n=19 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Tumor Response
PD
|
22 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Tumor Response
CR
|
7 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Tumor Response
PR
|
19 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Tumor Response
SD≥4 months
|
13 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Tumor Response
SD<4 months
|
11 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from the time measurement criteria are met for complete response, whichever is first recorded, until the first date in which progressive disease is objectively documented or the date of death, assessed up to 72 monthsPopulation: Cohort A: 26 patients showed response to treatment Events: 26 (100.0%) Cohort B SCLC: 10 patients showed response to treatment Events: 10 (100.0%) Cohort B: Endometrial: 8 patients showed response to treatment Events: 4 (50.0%)
The duration of overall response was measured from the time measurement criteria are met for complete response (CR)/ PR, whichever is first recorded, until the first date in which progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or the date of death. In absence of disease progression or death, the duration of response was censored on the date of last tumor evaluation.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=26 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=10 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
n=8 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response
|
7.2 months
Interval 3.4 to 8.6
|
5.2 months
Interval 1.0 to 6.9
|
7.5 months
Interval 6.4 to
Not reached
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from the date of first administration to the date of PD or death (of any cause), whichever came first, assessed up to 72 monthsPopulation: Cohort A: 1 patient was not evaluable: extensive bone marrow involvement Events: 66 (91.7%) Cohort B: SCLC Events: 28 (100.0%) Cohort B: Endometrial: Events: 14 (73.7%)
Progression-free survival (PFS) is defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death has not occurred at the time of the analysis, the PFS was censored on the date of last tumor evaluation.
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=72 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=28 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
n=19 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
3.8 months
Interval 2.6 to 5.3
|
3.3 months
Interval 1.4 to 6.2
|
7.7 months
Interval 2.0 to 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from the date of first administration to the date of death (of any cause), assessed up to 72 monthsPopulation: Cohort A: Events: 15 (20.5%); Cohort B: SCLC: Events: 22 (78.6%); Cohort B: Endometrial Events: 11 (57.9%)
Overall survival (OS) is defined as the time from the date of first infusion of study treatment to the date of death (due to any cause). Patients with no documented death were censored at the last date they are known to be alive
Outcome measures
| Measure |
Patients Without Primary G-CSF Prophylaxis
n=73 Participants
All participants who received at least one complete cycle study treatments without Primary G-CSF Prophylaxis
|
Patients With Primary G-CSF Prophylaxis
n=28 Participants
All participants who received at least one complete cycle study treatments with Primary G-CSF Prophylaxis
|
Cohort A: Dose I Without Primary G-CSF Proph and Age Limit
n=19 Participants
DOX 50 mg/m2 plus PM01183 3.5 mg FD and the Investigators and the Sponsor decided to amend the study's eligibility criteria, which originally did not establish a maximum age limit for the patients, in order to restrict accrual to patients aged between 18 and 75 years, both inclusive
|
Cohort A: Dose III Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose IV Without Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD without primary G-CSF prophylaxis
|
Cohort A: Dose I With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 3.5 mg FD. Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose III With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 4.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort A: Dose IV With Primary G-CSF Prophylaxis
DOX 50 mg/m2 plus PM01183 5.0 mg FD Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis.
However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I (DOX 50 mg/m2 plus PM01183 3.5 mg FD) in the present study suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis
|
Cohort B: DOX [mg/m2] Plus PM01183 [mg/m2]
DOX \[mg/m2\] plus PM01183 \[mg/m2\] Patient accrual into Cohort B started after the RD for the DOX/PM01183 combination had been defined in Cohort A. The dose evaluated in Cohort B was based on this RD, but the DOX dose was decreased to 40 mg/m2 and the PM01183 dose was changed to a BSA-based dose of 2.0 mg/m2 in order to improve the feasibility of this combination in patients with SCLC treated as second-line therapy and in patients with endometrial cancer. In accordance with the findings obtained in Cohort A, no patients in Cohort B received primary G-CSF prophylaxis.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
36.9 months
Interval 15.1 to
Not reached
|
7.9 months
Interval 4.2 to 11.5
|
14.2 months
Interval 4.5 to
Not reached
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A
Serious events: 47 serious events
Other events: 73 other events
Deaths: 15 deaths
Cohort B: SCLC 2nd Line
Serious events: 19 serious events
Other events: 28 other events
Deaths: 22 deaths
Cohort B: Endometrial
Serious events: 14 serious events
Other events: 18 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Cohort A
n=73 participants at risk
73 patients treated in Cohort A (DOX \[mg/m2\] plus PM01183 \[mg FD\]) were evaluable for safety
|
Cohort B: SCLC 2nd Line
n=28 participants at risk
Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
|
Cohort B: Endometrial
n=19 participants at risk
Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
|
|---|---|---|---|
|
Infections and infestations
Septic shock
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Lung infection
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Neutropenic infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Oesophageal candidiasis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Otitis media acute
|
1.4%
1/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Pneumonia
|
4.1%
3/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Respiratory tract infection
|
4.1%
3/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Sepsis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute monocytic leukaemia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Chest pain
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Fatigue
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
General physical health deterioration
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Pain
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Pyrexia
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Anaemia
|
5.5%
4/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
34.2%
25/73 • Number of events 32 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
14.3%
4/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.1%
4/19 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.3%
9/73 • Number of events 12 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
7/73 • Number of events 10 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
14.3%
4/28 • Number of events 11 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Ataxia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Cognitive disorder
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hydrocephalus
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Trigeminal nerve disorder
|
1.4%
1/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Renal and urinary disorders
Renal failure acute
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Escherichia sepsis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
Other adverse events
| Measure |
Cohort A
n=73 participants at risk
73 patients treated in Cohort A (DOX \[mg/m2\] plus PM01183 \[mg FD\]) were evaluable for safety
|
Cohort B: SCLC 2nd Line
n=28 participants at risk
Patients with SCLC 2nd line received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
|
Cohort B: Endometrial
n=19 participants at risk
Patients with endometrial cancer received the following on Day 1 q3wk (three weeks = one treatment cycle), administered: DOX 40 mg/m2 immediately followed by PM01183: 2.0 mg/m2.
|
|---|---|---|---|
|
General disorders
Malaise
|
5.5%
4/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Mucosal inflammation
|
46.6%
34/73 • Number of events 110 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
17.9%
5/28 • Number of events 19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
26.3%
5/19 • Number of events 12 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Oedema peripheral
|
9.6%
7/73 • Number of events 13 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Pain
|
5.5%
4/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Chest pain
|
8.2%
6/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Chills
|
5.5%
4/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Fatigue
|
90.4%
66/73 • Number of events 382 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
89.3%
25/28 • Number of events 118 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
89.5%
17/19 • Number of events 111 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Infusion site reaction
|
5.5%
4/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Hypotensions
|
8.2%
6/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
45.2%
33/73 • Number of events 67 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
25.0%
7/28 • Number of events 15 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Pyrexia
|
32.9%
24/73 • Number of events 35 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
17.9%
5/28 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Anxiety
|
13.7%
10/73 • Number of events 15 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Confusional state
|
5.5%
4/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Depression
|
17.8%
13/73 • Number of events 24 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Psychiatric disorders
Insomnia
|
12.3%
9/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
3/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Investigations
Weight decreased
|
20.5%
15/73 • Number of events 26 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.4%
6/28 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Cardiac disorders
Atrial fibrillation
|
4.1%
3/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.1%
30/73 • Number of events 73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
50.0%
14/28 • Number of events 19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
31.6%
6/19 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.5%
4/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.6%
26/73 • Number of events 52 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
39.3%
11/28 • Number of events 34 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
26.3%
5/19 • Number of events 10 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.5%
4/73 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
6/73 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.1%
3/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.6%
7/73 • Number of events 13 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Anaemia
|
53.4%
39/73 • Number of events 99 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
25.0%
7/28 • Number of events 26 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
26.3%
5/19 • Number of events 10 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.5%
31/73 • Number of events 75 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
35.7%
10/28 • Number of events 20 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
36.8%
7/19 • Number of events 60 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.0%
8/73 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
14.3%
4/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Dizziness
|
24.7%
18/73 • Number of events 28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
28.6%
8/28 • Number of events 12 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Dysaesthesia
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Dysgeusia
|
19.2%
14/73 • Number of events 32 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.1%
4/19 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Headache
|
11.0%
8/73 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
17.9%
5/28 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.1%
4/19 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Neurotoxicity
|
4.1%
3/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.3%
17/73 • Number of events 30 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Somnolence
|
5.5%
4/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Eye disorders
Conjunctivitis
|
6.8%
5/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Eye disorders
Lacrimation increased
|
5.5%
4/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Eye disorders
Vision blurred
|
5.5%
4/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
5/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
9/73 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
42.1%
8/19 • Number of events 22 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.7%
10/73 • Number of events 18 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Anal fissure
|
5.5%
4/73 • Number of events 10 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Constipation
|
45.2%
33/73 • Number of events 80 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
35.7%
10/28 • Number of events 18 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
47.4%
9/19 • Number of events 17 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Diarrhoea
|
41.1%
30/73 • Number of events 66 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.7%
3/28 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
47.4%
9/19 • Number of events 28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Dry mouth
|
19.2%
14/73 • Number of events 35 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Dyspepsia
|
11.0%
8/73 • Number of events 13 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
5/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Gastritis
|
5.5%
4/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.7%
10/73 • Number of events 17 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.5%
4/73 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Nausea
|
61.6%
45/73 • Number of events 158 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
67.9%
19/28 • Number of events 49 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
73.7%
14/19 • Number of events 64 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Vomiting
|
35.6%
26/73 • Number of events 79 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
42.9%
12/28 • Number of events 37 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
47.4%
9/19 • Number of events 21 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.1%
38/73 • Number of events 80 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
25.0%
7/28 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
52.6%
10/19 • Number of events 18 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.3%
9/73 • Number of events 19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.8%
5/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.5%
4/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
4/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.0%
8/73 • Number of events 19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.1%
4/19 • Number of events 7 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
12/73 • Number of events 23 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.4%
6/28 • Number of events 11 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.8%
5/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/73 • Number of events 8 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
21.1%
4/19 • Number of events 13 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.1%
11/73 • Number of events 19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
6/73 • Number of events 11 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
15.8%
3/19 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.3%
44/73 • Number of events 143 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
57.1%
16/28 • Number of events 36 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
31.6%
6/19 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.0%
8/73 • Number of events 13 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
4/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.3%
9/73 • Number of events 14 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 35 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Lower respiratory tract infection
|
4.1%
3/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
4/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Oral candidiasis
|
2.7%
2/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Paronychia
|
5.5%
4/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Pneumonia
|
1.4%
1/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Respiratory tract infection
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
14.3%
4/28 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/19 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
7/73 • Number of events 9 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Urinary tract infection
|
9.6%
7/73 • Number of events 11 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
7.1%
2/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Cardiac disorders
Palpitations
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Eye disorders
Dry eye
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Oral pain
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
General disorders
Asthenia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Bronchitis
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Cystitis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Device related infection
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Fungal infection
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Onychomycosis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Rhinitis
|
2.7%
2/73 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Sinusitis
|
2.7%
2/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Tooth abscess
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Ageusia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Aphonia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Nervous system disorders
Presyncope
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Renal and urinary disorders
Dysuria
|
2.7%
2/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
2/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 4 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
4.1%
3/73 • Number of events 6 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
2.7%
2/73 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodyaesthesia syndrome
|
1.4%
1/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
10.5%
2/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/73 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Flushing
|
1.4%
1/73 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Hypertension
|
4.1%
3/73 • Number of events 5 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
3.6%
1/28 • Number of events 3 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 2 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
|
Vascular disorders
Thrombophlebitis
|
1.4%
1/73 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
0.00%
0/28 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
5.3%
1/19 • Number of events 1 • Participants were assessed through study completion, approximately 6 years
All 120 patients treated in this study were evaluable for safety
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER