Trial Outcomes & Findings for European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer (NCT NCT03783949)
NCT ID: NCT03783949
Last Updated: 2025-06-11
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
COMPLETED
PHASE2
122 participants
3 years 10 months
2025-06-11
Participant Flow
Participant milestones
| Measure |
Standard Arm (Arm A)
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
First Experimental Arm (Arm B)
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Second Experimental Arm (Arm C)
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
39
|
|
Overall Study
COMPLETED
|
2
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
39
|
42
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
First Experimental Arm (Arm B)
n=42 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Second Experimental Arm (Arm C)
n=39 Participants
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Age, Continuous
|
63.77 years
STANDARD_DEVIATION 9.617 • n=99 Participants
|
61.78 years
STANDARD_DEVIATION 13.097 • n=107 Participants
|
62.76 years
STANDARD_DEVIATION 11.231 • n=206 Participants
|
62.76 years
STANDARD_DEVIATION 11.357 • n=7 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
12 participants
n=206 Participants
|
33 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=99 Participants
|
17 participants
n=107 Participants
|
17 participants
n=206 Participants
|
51 participants
n=7 Participants
|
|
Region of Enrollment
France
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
3 participants
n=206 Participants
|
17 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
17 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A).
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=80 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival
|
8.85 months
Interval 7.73 to 11.55
|
8.32 months
Interval 6.88 to 9.7
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free survival analysis in BRCA mutated patients
Outcome measures
| Measure |
Standard Arm (Arm A)
n=13 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=24 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in BRCA Mutated Patients
|
11.78 months
Interval 7.3 to 17.37
|
7.98 months
Interval 6.09 to 11.05
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Post-progression PFS (PFS2) analysis
Outcome measures
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=79 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Post-progression PFS (PFS2)
|
21.71 months
Interval 17.73 to 25.3
|
21.38 months
Interval 15.53 to 26.18
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Time to First Subsequent Therapy (TFST) analysis
Outcome measures
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=80 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Time to First Subsequent Therapy (TFST)
|
9.38 months
Interval 8.09 to 12.47
|
8.75 months
Interval 7.4 to 10.07
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Time to Second Subsequent Therapy (TSST) analysis
Outcome measures
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=80 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Time to Second Subsequent Therapy (TSST)
|
17.73 months
Interval 14.28 to 21.61
|
14.54 months
Interval 13.26 to 16.94
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free Survival analysis in Patients without BRCA mutation or with unknown BRCA status
Outcome measures
| Measure |
Standard Arm (Arm A)
n=28 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=56 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in Patients Without BRCA Mutation or With Unknown BRCA Status
|
7.83 months
Interval 6.58 to 11.38
|
8.49 months
Interval 6.71 to 10.49
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Objective response rate (ORR) analysis
Outcome measures
| Measure |
Standard Arm (Arm A)
n=38 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=79 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Objective Response Rate (ORR)
no response (SD/PD)
|
21 Participants
|
52 Participants
|
|
Objective Response Rate (ORR)
response (PR/CR)
|
17 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Overall survival (OS) analysis
Outcome measures
| Measure |
Standard Arm (Arm A)
n=41 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=81 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Overall Survival (OS)
|
22.14 months
Interval 17.73 to 29.97
|
22.27 months
Interval 17.07 to 29.21
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free Survival analysis in Patients with prior PARPi treatment
Outcome measures
| Measure |
Standard Arm (Arm A)
n=13 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=25 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in Patients With Prior PARPi Treatment
|
7.40 months
Interval 5.63 to 8.85
|
6.09 months
Interval 2.76 to 7.76
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free Survival analysis in Patients with one prior line of therapy
Outcome measures
| Measure |
Standard Arm (Arm A)
n=27 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=46 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in Patients With One Prior Line of Therapy
|
10.59 months
Interval 5.92 to 11.94
|
9.70 months
Interval 7.14 to 11.35
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free Survival analysis in Patients with more then one prior line of therapy
Outcome measures
| Measure |
Standard Arm (Arm A)
n=14 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=34 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in Patients With More Then One Prior Line of Therapy
|
7.63 months
Interval 7.3 to 12.89
|
7.43 months
Interval 4.11 to 8.32
|
SECONDARY outcome
Timeframe: 3 years 10 monthsPopulation: The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes.
Progression-free Survival analysis in Patients without prior PARPi treatment
Outcome measures
| Measure |
Standard Arm (Arm A)
n=28 Participants
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
Experimental Arms (Arm B&C)
n=55 Participants
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment:
Arm B: Niraparib (200/ 300 mg oral daily, q4w) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
|---|---|---|
|
Progression-free Survival in Patients Without Prior PARPi Treatment
|
11.55 months
Interval 7.43 to 13.55
|
9.77 months
Interval 7.83 to 11.12
|
Adverse Events
Standard Arm (Arm A) - Chemotherapy Phase
First Experimental Arm (Arm B) - Chemotherapy Phase
Second Experimental Arm (Arm C) - Chemotherapy Phase
Standard Arm (Arm A) - Maintenance Phase
First Experimental Arm (Arm B) - Maintenance Phase
Second Experimental Arm (Arm C) - Maintenance Phase
Serious adverse events
| Measure |
Standard Arm (Arm A) - Chemotherapy Phase
n=41 participants at risk
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
First Experimental Arm (Arm B) - Chemotherapy Phase
n=42 participants at risk
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Second Experimental Arm (Arm C) - Chemotherapy Phase
n=39 participants at risk
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Standard Arm (Arm A) - Maintenance Phase
n=32 participants at risk
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
|
First Experimental Arm (Arm B) - Maintenance Phase
n=26 participants at risk
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w)
|
Second Experimental Arm (Arm C) - Maintenance Phase
n=17 participants at risk
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w)
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Anaphylactic shock
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Infections and infestations
CRP increased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.5%
4/42 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Immune system disorders
allergic reaction NOS
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Immune system disorders
Allergic reaction to Carboplatin
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
4.8%
2/42 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
3/39 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Ascites
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
4.8%
2/42 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Dehydration
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Fistula
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
general deterioration
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
General malaise
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Hypokalemia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Intestinal subobstruction
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Renal and urinary disorders
Kidney insufficiency
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Maligne pleuritis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Neutropenia
|
19.5%
8/41 • Number of events 8 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary tuberculosis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Infections and infestations
Septic shock
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Syncope
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Thrombocytopenia
|
7.3%
3/41 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Tumor biopsy
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Bilirubin increased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Fever
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Gastro-entiritis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Headache
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Infections and infestations
Infection
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
transaminases increased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Word finding disorders
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
Other adverse events
| Measure |
Standard Arm (Arm A) - Chemotherapy Phase
n=41 participants at risk
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w)
Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 \& d8)
|
First Experimental Arm (Arm B) - Chemotherapy Phase
n=42 participants at risk
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Second Experimental Arm (Arm C) - Chemotherapy Phase
n=39 participants at risk
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
|
Standard Arm (Arm A) - Maintenance Phase
n=32 participants at risk
Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w)
Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
|
First Experimental Arm (Arm B) - Maintenance Phase
n=26 participants at risk
Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w)
|
Second Experimental Arm (Arm C) - Maintenance Phase
n=17 participants at risk
Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
QTc prolongation
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.1%
3/42 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
abdominal cramping
|
7.3%
3/41 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Abdominal pain
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.5%
4/42 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
3/39 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Immune system disorders
Allergic reaction to Carboplatin
|
14.6%
6/41 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
21.4%
9/42 • Number of events 9 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
28.2%
11/39 • Number of events 11 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Alopecia
|
14.6%
6/41 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Anemia
|
78.0%
32/41 • Number of events 32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
61.9%
26/42 • Number of events 26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
64.1%
25/39 • Number of events 25 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
56.2%
18/32 • Number of events 18 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
46.2%
12/26 • Number of events 12 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
41.2%
7/17 • Number of events 22 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Anorexia
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.5%
4/42 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
10.3%
4/39 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Asthenia
|
29.3%
12/41 • Number of events 12 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
38.1%
16/42 • Number of events 16 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
25.6%
10/39 • Number of events 10 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
15.4%
4/26 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
35.3%
6/17 • Number of events 16 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Eye disorders
blurry vision
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
11/41 • Number of events 11 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
16.7%
7/42 • Number of events 7 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
23.1%
9/39 • Number of events 9 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
21.9%
7/32 • Number of events 7 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
19.2%
5/26 • Number of events 5 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
23.5%
4/17 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
6/41 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
45.2%
19/42 • Number of events 19 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
51.3%
20/39 • Number of events 20 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.4%
3/32 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.5%
3/26 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
70.6%
12/17 • Number of events 40 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Dizziness
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
4.8%
2/42 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Dysgeusia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.5%
3/26 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Epigastric pain
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.1%
2/39 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Epistaxis
|
7.3%
3/41 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Fatigue
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
12.5%
4/32 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
29.4%
5/17 • Number of events 5 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
General malaise
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.1%
3/42 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Headache
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.1%
3/42 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
23.1%
6/26 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
17.6%
3/17 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Insomnia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.1%
2/39 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Leucocytopenia
|
68.3%
28/41 • Number of events 28 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
28.6%
12/42 • Number of events 12 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
25.6%
10/39 • Number of events 10 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
31.2%
10/32 • Number of events 10 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.5%
4/42 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Nausea
|
53.7%
22/41 • Number of events 22 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
59.5%
25/42 • Number of events 25 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
41.0%
16/39 • Number of events 16 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
31.2%
10/32 • Number of events 10 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
26.9%
7/26 • Number of events 7 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
76.5%
13/17 • Number of events 13 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Neutropenia
|
85.4%
35/41 • Number of events 55 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
45.2%
19/42 • Number of events 26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
43.6%
17/39 • Number of events 22 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Nervous system disorders
Peripheral neuropathy
|
2.4%
1/41 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.1%
3/42 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
53.1%
17/32 • Number of events 17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
23.1%
6/26 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
35.3%
6/17 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
3/41 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.1%
2/39 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Stomach pain
|
9.8%
4/41 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Syncope
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
4.8%
2/42 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.1%
2/39 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Thrombocytopenia
|
85.4%
35/41 • Number of events 35 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
69.0%
29/42 • Number of events 29 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
74.4%
29/39 • Number of events 29 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
34.4%
11/32 • Number of events 11 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
53.8%
14/26 • Number of events 14 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
29.4%
5/17 • Number of events 5 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Transaminases increased
|
26.8%
11/41 • Number of events 11 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.9%
5/42 • Number of events 5 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
15.4%
6/39 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.4%
3/32 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.9%
2/41 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.4%
1/42 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
2.6%
1/39 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
17.6%
3/17 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
6/41 • Number of events 6 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
26.2%
11/42 • Number of events 11 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
23.1%
9/39 • Number of events 9 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.4%
3/32 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
15.4%
4/26 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
41.2%
7/17 • Number of events 7 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
QTcF prolongation
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.1%
2/39 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Abdominal bloating
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Alkaline phosphatase increased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Investigations
Creatinine increased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.1%
1/32 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
9.4%
3/32 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.5%
3/26 • Number of events 3 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Skin and subcutaneous tissue disorders
itching
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/17 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Gastrointestinal disorders
Pyrosis
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/32 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
3.8%
1/26 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
11.8%
2/17 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
12.5%
4/32 • Number of events 4 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
7.7%
2/26 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
|
General disorders
Weight decreased
|
0.00%
0/41 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/42 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/39 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
6.2%
2/32 • Number of events 2 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
0.00%
0/26 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
5.9%
1/17 • Number of events 1 • 3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place