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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

3 years 10 months

Results posted on

2025-06-11

Participant Flow

Participant milestones

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

Serious events: 20 serious events
Other events: 40 other events
Deaths: 41 deaths

First Experimental Arm (Arm B) - Chemotherapy Phase

Serious events: 19 serious events
Other events: 42 other events
Deaths: 42 deaths

Second Experimental Arm (Arm C) - Chemotherapy Phase

Serious events: 16 serious events
Other events: 39 other events
Deaths: 39 deaths

Standard Arm (Arm A) - Maintenance Phase

Serious events: 13 serious events
Other events: 32 other events
Deaths: 32 deaths

First Experimental Arm (Arm B) - Maintenance Phase

Serious events: 8 serious events
Other events: 26 other events
Deaths: 26 deaths

Second Experimental Arm (Arm C) - Maintenance Phase

Serious events: 5 serious events
Other events: 17 other events
Deaths: 17 deaths

Serious adverse events

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

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

Ellen Reynders, SC

UZLeuven

Phone: +3216342996

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place